Latest news with #CHMP
Business Wire
16 hours ago
- Business
- Business Wire
BeOne Medicines Receives Positive CHMP Opinion for Tablet Formulation of BRUKINSA ®
BASEL, Switzerland--(BUSINESS WIRE)-- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of a new film-coated tablet formulation of BRUKINSA ® (zanubrutinib) for all approved indications. The CHMP positive opinion will now be reviewed by the European Commission, which will grant the marketing authorization for the tablet formulation in the European Union and in the European Economic Area countries Norway and Iceland. 'The CHMP's positive opinion of our new tablet formulation of BRUKINSA is an important step toward bringing this thoughtful, patient-centered innovation to people facing certain B-cell cancers across Europe,' said Giancarlo Benelli, Senior Vice President and Head of Europe, BeOne. 'We look forward to a potential approval later this year and remain committed to delivering our impactful medicines to more patients in the region.' The BRUKINSA tablets have been shown to be bioequivalent to the BRUKINSA capsules based on the results of two single-dose, open-label, randomized Phase 1 crossover studies in healthy subjects. The recommended dose of BRUKINSA remains – 320 mg daily. The BRUKINSA tablets are 160 mg each, allowing patients to halve their daily pill intake and take two tablets daily. The new tablet formulation maintains BRUKINSA's dosing flexibility by providing patients and prescribers with the option of once- or twice-daily dosing and is designed to simplify management of dose reductions as per label recommendation. Additionally, the BRUKINSA tablets are smaller than the capsules and have a film coat, which makes them easier to swallow. BeOne Medicines will begin to convert BRUKINSA from capsules to tablets in regions outside China in 2025 as part of our commitment to sustainable business practices, including reducing our impact on the environment. This adjustment will decrease the bottle size by ~70% while also enabling the shipment of this medication with reduced temperature controls, which we expect to reduce energy needs, greenhouse gas emissions, and global transport costs. Today's announcement follows the U.S. Food and Drug Administration (FDA) approval of the new tablet formulation of BRUKINSA for all five approved indications earlier this month. In the U.S., BRUKINSA is the leader in new patient starts for chronic lymphocytic leukemia (CLL) across all lines of therapy, and for the first time, has become the overall BTK inhibitor market share leader. 1 Important Safety Information The current European Summary of Product Characteristics (SmPC) of BRUKINSA is available from the website of the European Medicines Agency. This information is intended for a global audience. Product indications vary by region. About BeOne Medicines BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the future potential approval of the tablet formulation of BRUKINSA by the European Commission and the timing of such approval; and BeOne's plans, commitments, aspirations, and goals under the heading 'About BeOne.' Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit our Newsroom.
Business Upturn
3 days ago
- Business
- Business Upturn
European Medicines Agency Recommends Market Approval of AVT06, Alvotech's Proposed Biosimilar to Eylea® (aflibercept)
REYKJAVIK, Iceland and LONDON, June 23, 2025 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human use (CHMP) adopted a positive opinion recommending approval for AVT06, Alvotech's proposed biosimilar to Eylea® (aflibercept 2 mg). Based on a positive recommendation by CHMP, biosimilar medicines can be approved by the European Commission for marketing in the European Economic Area, that includes the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein. 'CHMP's positive opinion takes us a step closer to being able to market our proposed biosimilar in Europe, which is excellent news for patients and their caregivers. Alvotech looks forward to increasing access to this vital biologic treatment for eye disorders,' said Joseph McClellan, Chief Scientific Officer of Alvotech. Advertisement 'We are pleased with the CHMP's positive opinion, which marks an important milestone in our mission to bring high-quality, specialist medicines to patients across Europe,' said Nick Warwick, Chief Medical Officer of Advanz Pharma. The CHMP opinion recommends granting of a marketing authorization for AVT06 intended for the treatment of adults with neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV). Alvotech is responsible for the development and commercial supply of the proposed biosimilar. Advanz Pharma is responsible for registration and has exclusive commercialization rights for most countries in Europe. In 2024, global sales of Eylea® were about US$9 billion, and one third of these sales were in Europe [1]. In January 2024 Alvotech announced positive top-line results from a confirmatory clinical study with AVT06 (AVT06-GL-C01) comparing the efficacy, safety, and immunogenicity of the proposed biosimilar to Eylea® in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech's biosimilar candidate and Eylea® [2]. Alvotech is also developing AVT29, a proposed biosimilar to Eylea® HD, a higher dose (aflibercept 8 mg) aflibercept. Advanz has licensed the distribution rights from Alvotech for both biosimilar candidates, for the same territory. About AVT06 (aflibercept) AVT06 is a recombinant fusion protein and a biosimilar candidate to Eylea® (aflibercept), which binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [3]. AVT06 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. Sources [1] Global Data and IQVIA [2] Agostini, H. (2025). A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. Expert Opinion on Biological Therapy, 1–15. [3] Use of trademarks Elyea® is a registered trademark of Regeneron Pharmaceuticals Inc. and Bayer AG. About Alvotech Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech's current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech's commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit . None of the information on the Alvotech website shall be deemed part of this press release. About Advanz Pharma Partner of choice in specialty, hospital, and rare disease medicines. Advanz Pharma is a global pharmaceutical company with the purpose to improve patients' lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network. Advanz Pharma's product portfolio and pipeline comprises innovative medicines, biosimilars & specialty generics, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, rheumatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity. Alvotech Forward Looking Statements Certain statements in this communication may be considered 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial or operating performance of Alvotech and may include, for example, Alvotech's expectations regarding future growth, results of operations, performance, future capital and other expenditures, competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory review and interactions, the satisfactory responses to the FDA's inspection findings and resolution of other deficiencies conveyed following the re-inspection of Alvotech's manufacturing site, the potential approval, including for AVT02, AVT04, and the product candidates in scope of the partnership with Advanz, by the FDA and other regulatory agencies and commercial launch of its product candidates, the timing of the announcement of clinical study results, the commencement of patient studies, regulatory applications, approvals and market launches, and the estimated size of the total addressable market of Alvotech's pipeline products. In some cases, you can identify forward-looking statements by terminology such as 'may', 'should', 'expect', 'intend', 'will', 'estimate', 'anticipate', 'believe', 'predict', 'potential' or 'continue', or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech's control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability to reach development milestones under commercial partnership agreements including the partnership with Advanz; (2) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (3) the ability to maintain stock exchange listing; (4) changes in applicable laws or regulations; (5) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (6) Alvotech's estimates of expenses and profitability; (7) Alvotech's ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (10) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (11) the ability of Alvotech or its partners, including Advanz, to gain approval from regulators for planned clinical studies, study plans or sites; (12) the ability of Alvotech's partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (13) Alvotech's ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (14) the success of Alvotech's current and future collaborations, joint ventures, partnerships or licensing arrangements, including the partnership with Advanz; (15) Alvotech's ability, and that of its commercial partners, including Advanz, to execute their commercialization strategy for approved products; (16) Alvotech's ability to manufacture sufficient commercial supply of its approved products; (17) the outcome of ongoing and future litigation regarding Alvotech's products and product candidates; (18) the potential impact of the ongoing COVID-19 pandemic on the FDA's review timelines, including its ability to complete timely inspection of manufacturing sites; (19) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, war in Ukraine and global geopolitical tension, and the ongoing and evolving COVID-19 pandemic on the Alvotech's business, financial position, strategy and anticipated milestones; and (20) other risks and uncertainties set forth in the sections entitled 'Risk Factors' and 'Cautionary Note Regarding Forward-Looking Statements' in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication. Advanz Pharma Forward Looking Statements Certain statements in this press release are forward-looking statements. These statements may be identified by words such as 'anticipate', 'expectation', 'belief', 'estimate', 'plan', 'target', 'project', 'will', 'may', 'should' or 'forecast' and similar expressions, or by their context. Although Advanz Pharma believes that these assumptions were reasonable when made, by their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions affecting the industry, intense competition in the markets in which Advanz Pharma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Advanz Pharma's markets, and other factors beyond the control of Advanz Pharma. Neither Advanz Pharma nor any of its directors, officers, employees, advisors, or any other person is under any obligation to update or keep current the information contained in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this press release. Statements contained in this press release regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. No obligation is assumed to update any forward-looking statements. The information contained in this press release is provided as at the date of this document and is subject to change without notice. MEDIA CONTACTS Alvotech Global Communications and Investor Relations Benedikt Stefansson [email protected] Advanz Pharma Global Corporate Communications Courtney Baines [email protected] Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.
Yahoo
3 days ago
- Health
- Yahoo
Press Release: Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma
Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma Recommendation based on GMMG-HD7 phase 3 study demonstrating that Sarclisa with VRd induction treatment significantly improved MRD negativity benefit and prolonged PFS compared to VRd alone If approved, it would represent the fourth indication in the EU and second in the front-line setting globally Paris, June 23, 2025. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. A final decision is expected in the coming months. Global Head, Oncology'The CHMP's recommendation represents significant progress toward our ambition for Sarclisa, addressing unmet patient needs in multiple myeloma care and making a meaningful difference in treatment outcomes at every stage of the disease across regions. If approved, this regimen would represent a new, important induction option for transplant-eligible patients, with the potential to improve long-term outcomes and deepen responses at a critical juncture in treatment.' The positive CHMP opinion is based on part one results from the two-part, double-randomized, German-speaking Myeloma Multicenter Group (GMMG)-HD7 study (clinical study identifier: NCT03617731), presented at the 2024 American Society of Hematology Annual Meeting & Exposition and published in the Journal of Clinical Oncology. GMMG-HD7 is the first phase 3 study to demonstrate a deep and rapid response with an anti-CD38-based induction regimen in transplant-eligible (TE) NDMM patients, with a higher proportion of patients with minimal residual disease (MRD) negativity benefit post-induction, alongside a significant progression-free survival (PFS) benefit from first randomization, regardless of maintenance therapy and without consolidation. Additionally, the data showed the highest post-induction and post-transplant MRD negativity rates of any CD38 monoclonal antibody using VRd as a backbone in TE NDMM. The results are part of the growing body of clinical evidence supporting the use of Sarclisa in the front-line setting and reinforce the potential of Sarclisa-VRd when used prior to transplant. Sarclisa is currently approved in three indications in the EU, across different lines of therapy in adult patients with relapsed and/or refractory (R/R) MM and with NDMM who are not eligible for transplant. About the GMMG-HD7 studyGMMG-HD7 is an investigational pivotal, randomized, open-label, multicenter, two-part phase 3 study evaluating Sarclisa in combination with VRd, also referred to as RVd (lenalidomide, bortezomib, and dexamethasone), versus VRd induction followed by post-transplant re-randomization to Sarclisa plus lenalidomide versus lenalidomide maintenance in TE NDMM patients. The GMMG-initiated study is being conducted in close collaboration with Sanofi based on jointly defined research. Sanofi provided financial support to GMMG for this study. In December 2021, Sanofi and GMMG shared results from part one, which met the primary endpoint of MRD negativity after induction therapy and before transplant in NDMM patients. The study enrolled 662 patients with TE NDMM across 67 sites in Germany. In the first part of the study, all participants were equally randomized to receive three 42-day cycles of VRd in both arms of the study, while Sarclisa was added to only one study arm. In the second part of the study, patients were re-randomized post-transplant to receive Sarclisa plus lenalidomide or lenalidomide alone as maintenance therapy. During the study, Sarclisa was administered through an intravenous infusion at a dose of 10 mg/kg once weekly for the first four weeks of cycle one, then every other week for the rest of the induction period. The GMMG-HD7 protocol defined two primary endpoints: MRD negativity following induction therapy in the first part of the study, and PFS after the second randomization post-transplant in the second part, where Sarclisa was added to lenalidomide maintenance. The latter endpoint is expected to be available at a later time. The key secondary endpoint for the first part of the study was PFS from first randomization. Additional secondary endpoints included rates of complete response after induction, and intensification, overall survival, and safety. MRD negativity was assessed by next-generation flow cytometry (sensitivity of 1x10-5) after induction. In the latest results, PFS for both arms, regardless of maintenance therapy, were measured from the first randomization. About SarclisaSarclisa (isatuximab) is approved in more than 50 countries, including in the US, EU, Japan, and China, across multiple treatment lines for MM. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in the US, EU and Japan in combination with pomalidomide and dexamethasone for the treatment of patients with R/R MM who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor and have relapsed on the last therapy; this combination is also approved in China for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Based on the IKEMA phase 3 study, Sarclisa is also approved in more than 50 countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received one to three prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy. In the US, EU, UK, and China, Sarclisa is approved in combination with VRd as a front-line treatment option in transplant-ineligible NDMM patients, based on the IMROZ phase 3 study. In Japan, Sarclisa is approved in combination with VRd as a front-line treatment option regardless of transplant eligibility. At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need. For more information on Sarclisa clinical studies, please visit About the German-speaking Myeloma Multicenter Group GMMG is the largest study group focusing on MM in Germany, with headquarters based in Heidelberg. Within the last 20+ years, the GMMG study group has performed numerous studies including five randomized, multicenter phase 3 studies with 4,000 patients enrolled from about 90 participating and cotreating centers throughout Germany. The overall goal of GMMG is to generate improved therapies for myeloma patients through the development and testing of novel and personalized, genome- and signaling driven treatment strategies. The GMMG has set itself the goal of achieving further approvals for effective antibody-based drug combinations for the first-line treatment of myeloma patients, in which antibody-based treatment regimens have been integrated into seven GMMG study concepts (CONCEPT, DANTE, DADA, HD6, HD7, HD8, HD9 and HD10). About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | +33 6 25 09 14 25 | Evan Berland | +1 215 432 0234 | Le Bourhis | +33 6 75 06 43 81 | Rouault | +33 6 70 93 71 40 | Timothy Gilbert | +1 516 521 2929 | Léa Ubaldi | +33 6 30 19 66 46 | Investor RelationsThomas Kudsk Larsen | +44 7545 513 693 | Kaisserian | +33 6 47 04 12 11 | Felix Lauscher | +1 908 612 7239 | Keita Browne | +1 781 249 1766 | Nathalie Pham | +33 7 85 93 30 17 | Tarik Elgoutni | +1 617 710 3587 | Thibaud Châtelet | +33 6 80 80 89 90 | Yun Li | +33 6 84 00 90 72 | Sanofi forward-looking statementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words 'expects', 'anticipates', 'believes', 'intends', 'estimates', 'plans', and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under 'Risk Factors' and 'Cautionary Statement Regarding Forward-Looking Statements' in Sanofi's annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi Press_Release
Yahoo
3 days ago
- Health
- Yahoo
Press Release: Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma
Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma Recommendation based on GMMG-HD7 phase 3 study demonstrating that Sarclisa with VRd induction treatment significantly improved MRD negativity benefit and prolonged PFS compared to VRd alone If approved, it would represent the fourth indication in the EU and second in the front-line setting globally Paris, June 23, 2025. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. A final decision is expected in the coming months. Global Head, Oncology'The CHMP's recommendation represents significant progress toward our ambition for Sarclisa, addressing unmet patient needs in multiple myeloma care and making a meaningful difference in treatment outcomes at every stage of the disease across regions. If approved, this regimen would represent a new, important induction option for transplant-eligible patients, with the potential to improve long-term outcomes and deepen responses at a critical juncture in treatment.' The positive CHMP opinion is based on part one results from the two-part, double-randomized, German-speaking Myeloma Multicenter Group (GMMG)-HD7 study (clinical study identifier: NCT03617731), presented at the 2024 American Society of Hematology Annual Meeting & Exposition and published in the Journal of Clinical Oncology. GMMG-HD7 is the first phase 3 study to demonstrate a deep and rapid response with an anti-CD38-based induction regimen in transplant-eligible (TE) NDMM patients, with a higher proportion of patients with minimal residual disease (MRD) negativity benefit post-induction, alongside a significant progression-free survival (PFS) benefit from first randomization, regardless of maintenance therapy and without consolidation. Additionally, the data showed the highest post-induction and post-transplant MRD negativity rates of any CD38 monoclonal antibody using VRd as a backbone in TE NDMM. The results are part of the growing body of clinical evidence supporting the use of Sarclisa in the front-line setting and reinforce the potential of Sarclisa-VRd when used prior to transplant. Sarclisa is currently approved in three indications in the EU, across different lines of therapy in adult patients with relapsed and/or refractory (R/R) MM and with NDMM who are not eligible for transplant. About the GMMG-HD7 studyGMMG-HD7 is an investigational pivotal, randomized, open-label, multicenter, two-part phase 3 study evaluating Sarclisa in combination with VRd, also referred to as RVd (lenalidomide, bortezomib, and dexamethasone), versus VRd induction followed by post-transplant re-randomization to Sarclisa plus lenalidomide versus lenalidomide maintenance in TE NDMM patients. The GMMG-initiated study is being conducted in close collaboration with Sanofi based on jointly defined research. Sanofi provided financial support to GMMG for this study. In December 2021, Sanofi and GMMG shared results from part one, which met the primary endpoint of MRD negativity after induction therapy and before transplant in NDMM patients. The study enrolled 662 patients with TE NDMM across 67 sites in Germany. In the first part of the study, all participants were equally randomized to receive three 42-day cycles of VRd in both arms of the study, while Sarclisa was added to only one study arm. In the second part of the study, patients were re-randomized post-transplant to receive Sarclisa plus lenalidomide or lenalidomide alone as maintenance therapy. During the study, Sarclisa was administered through an intravenous infusion at a dose of 10 mg/kg once weekly for the first four weeks of cycle one, then every other week for the rest of the induction period. The GMMG-HD7 protocol defined two primary endpoints: MRD negativity following induction therapy in the first part of the study, and PFS after the second randomization post-transplant in the second part, where Sarclisa was added to lenalidomide maintenance. The latter endpoint is expected to be available at a later time. The key secondary endpoint for the first part of the study was PFS from first randomization. Additional secondary endpoints included rates of complete response after induction, and intensification, overall survival, and safety. MRD negativity was assessed by next-generation flow cytometry (sensitivity of 1x10-5) after induction. In the latest results, PFS for both arms, regardless of maintenance therapy, were measured from the first randomization. About SarclisaSarclisa (isatuximab) is approved in more than 50 countries, including in the US, EU, Japan, and China, across multiple treatment lines for MM. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in the US, EU and Japan in combination with pomalidomide and dexamethasone for the treatment of patients with R/R MM who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor and have relapsed on the last therapy; this combination is also approved in China for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Based on the IKEMA phase 3 study, Sarclisa is also approved in more than 50 countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received one to three prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy. In the US, EU, UK, and China, Sarclisa is approved in combination with VRd as a front-line treatment option in transplant-ineligible NDMM patients, based on the IMROZ phase 3 study. In Japan, Sarclisa is approved in combination with VRd as a front-line treatment option regardless of transplant eligibility. At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need. For more information on Sarclisa clinical studies, please visit About the German-speaking Myeloma Multicenter Group GMMG is the largest study group focusing on MM in Germany, with headquarters based in Heidelberg. Within the last 20+ years, the GMMG study group has performed numerous studies including five randomized, multicenter phase 3 studies with 4,000 patients enrolled from about 90 participating and cotreating centers throughout Germany. The overall goal of GMMG is to generate improved therapies for myeloma patients through the development and testing of novel and personalized, genome- and signaling driven treatment strategies. The GMMG has set itself the goal of achieving further approvals for effective antibody-based drug combinations for the first-line treatment of myeloma patients, in which antibody-based treatment regimens have been integrated into seven GMMG study concepts (CONCEPT, DANTE, DADA, HD6, HD7, HD8, HD9 and HD10). About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | +33 6 25 09 14 25 | Evan Berland | +1 215 432 0234 | Le Bourhis | +33 6 75 06 43 81 | Rouault | +33 6 70 93 71 40 | Timothy Gilbert | +1 516 521 2929 | Léa Ubaldi | +33 6 30 19 66 46 | Investor RelationsThomas Kudsk Larsen | +44 7545 513 693 | Kaisserian | +33 6 47 04 12 11 | Felix Lauscher | +1 908 612 7239 | Keita Browne | +1 781 249 1766 | Nathalie Pham | +33 7 85 93 30 17 | Tarik Elgoutni | +1 617 710 3587 | Thibaud Châtelet | +33 6 80 80 89 90 | Yun Li | +33 6 84 00 90 72 | Sanofi forward-looking statementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words 'expects', 'anticipates', 'believes', 'intends', 'estimates', 'plans', and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under 'Risk Factors' and 'Cautionary Statement Regarding Forward-Looking Statements' in Sanofi's annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi Press_ReleaseSign in to access your portfolio
Medscape
5 days ago
- Health
- Medscape
EMA Reviews Alcohol Dependency Drug After French Concerns
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced it will review the use of medicines containing sodium oxybate, a drug used in narcolepsy, in people with alcohol dependency. The review comes at the request of the French Medicines Agency and has been initiated under Article 31 of Directive 2001/83/EC. This procedure is used to address concerns over the safety or benefit-risk balance of a medicine or a class of medicines; to resolve disagreements between member states on issues related to the authorization of medicines; or to give an opinion on an issue of Europe-wide interest so that the agency can make a recommendation for a harmonized position across the EU. The European Commission, any member state, or the company that markets the medicine can initiate a referral. In a referral, the European Medicines Agency (EMA) is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the European Union. It involves the matter being referred to the Pharmacovigilance Risk Assessment Committee (PRAC) after due notice to the EMA, all member states, and the European Commission. Narcolepsy Indication Sodium oxybate (Xyrem) is the sodium salt of gamma-hydroxybutyric acid. As an oral solution (500 mg/mL), it is indicated for the treatment of narcolepsy with cataplexy in adult patients, adolescents, and children from the age of 7 years. The drug is a central nervous system depressant believed to act by attaching to brain cell receptor molecules to promote delta (slow) brain waves and nighttime sleep. When taken at bedtime, Xyrem increases sleep depth and length, reducing the number of sleeping periods during the day and improving symptoms of narcolepsy. Because of the drug's potential for abuse, it can only be obtained with a special prescription, and treatment should be initiated and maintained under the guidance of a doctor with experience in treating sleep disorders. Doctors are advised to check for a history of or susceptibility to drug abuse before treatment, and to monitor for misuse and abuse during treatment. Approved for Alcohol Abuse in Austria and Italy The drug has also been suggested to reduce pain and improve function in fibromyalgia, but the EMA said the data were insufficient to support its use for this in the European population. However, sodium oxybate is also approved in Italy and in Austria, under the name Alcover, to treat alcohol dependence and alcohol withdrawal syndrome. It is this use that the review will examine. The EMA has confirmed the positive benefit-risk profile of the treatment as prescribed in Italy and Austria. France, however, despite having a high prevalence of alcohol problems, has resisted its use for this purpose. Trials have suggested that sodium oxybate can rapidly alleviate symptoms of alcohol withdrawal syndrome and was at least as effective as diazepam and clomethiazole. It can also be used in the maintenance of abstinence in alcohol-dependent patients, in whom it is reportedly as effective as naltrexone or disulfiram. Because existing approved medications are only modestly effective, there is a pressing need for effective treatments with an alternative mode of action, particularly in patients with very high consumption levels. Sodium oxybate also has a favorable safety profile. However, studies in alcohol use disorder have been limited and further investigations have been recommended.
