Latest news with #CHMP
Yahoo
26-05-2025
- Business
- Yahoo
Bayer Gets CHMP Nod for Eylea 8 mg in the EU for 2 Major Eye Diseases
Bayer BAYRY announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the label extension for Eylea 8 mg (aflibercept) in the EU. This extension will enable longer treatment intervals, up to six months, for two major retinal conditions, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME), pending approval by the European Commission. A decision is anticipated in the coming weeks. If approved, Eylea 8 mg would become the only anti-VEGF therapy in the EU offering treatment intervals of up to six months for both nAMD and DME. Such a decision will also significantly reduce the frequency of injections and clinic visits, which will boost patient compliance and treatment adherence. Year to date, shares of Bayer have surged 41.8% against the industry's decline of 5.2%. Image Source: Zacks Investment Research The favorable CHMP opinion is supported by positive three-year results from Bayer's open-label extension studies of the pivotal PULSAR study for nAMD and the PHOTON study for DME. In these studies, patients initially randomized to receive Eylea 8 mg maintained their visual and anatomical improvements over three years. By the end of the studies, 24% of nAMD patients and 28% of DME patients had reached a final dosing interval of six months. Eylea 8 mg continued to demonstrate a favorable safety profile in the third year, consistent with the well-established safety profile of Eylea 2 mg. Long-term safety data revealed no new safety concerns, including among patients who transitioned from Eylea 2 mg to Eylea 8 mg. The incidence of ocular treatment-emergent adverse events was comparable across all treatment groups. Please note that Eylea is a blockbuster drug for treating retinal eye diseases. Eylea 8 mg is currently approved in more than 50 markets for treating nAMD and DME. Several applications seeking the drug's regulatory approvals in additional markets are ongoing. Eylea 8 mg is also the only anti-VEGF therapy approved in the EU and United Kingdom for extended treatment intervals of up to five months, following three initial monthly injections, for both nAMD and DME. Bayer's HealthCare unit co-develops Eylea with Regeneron REGN. REGN records net product sales of Eylea in the United States, while BAYRY records net product sales of the drug outside the country. Regeneron also records its share of profits/losses in connection with the sales of Eylea outside the United States. Bayer Aktiengesellschaft price-consensus-chart | Bayer Aktiengesellschaft Quote Bayer currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the biotech sector are Halozyme Therapeutics HALO and Amarin AMRN, each carrying a Zacks Rank #2 at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. In the past 60 days, estimates for Halozyme's earnings per share have increased from $5.02 to $5.23 for 2025. During the same time, earnings per share estimates for 2026 have increased from $6.56 to $6.77. Year to date, shares of HALO have risen 12.4%. HALO's earnings beat estimates in each of the trailing four quarters, with the average surprise being 17.60%. In the past 60 days, estimates for Amarin's loss per share have narrowed from $5.33 to $3.48 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.13 to $2.67. Year to date, shares of AMRN have gained 13.3%. AMRN's earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report Halozyme Therapeutics, Inc. (HALO) : Free Stock Analysis Report Amarin Corporation PLC (AMRN) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
26-05-2025
- Business
- Globe and Mail
Roche Gets CHMP Nod for Itovebi Combo in the EU for Breast Cancer
Roche RHHBY announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Itovebi (inavolisib) therapy for breast cancer. A final decision from the European Commission is expected soon. The company is seeking approval for a combination regimen of Itovebi with Pfizer 's PFE Ibrance (palbociclib) and AstraZeneca 's AZN Faslodex (fulvestrant). The intended treatment population includes adult patients with PIK3CA - mutated, ER-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. PFE's Ibrance and AZN's Faslodex are both currently approved for breast cancer treatment. Please note that Roche's Itovebi, in combination with Pfizer's Ibrance and AstraZeneca's Faslodex, is currently approved for the same indication as above in several geographies, including the United States, with additional applications under review by other regulatory authorities worldwide. Year to date, shares of RHHBY have surged 13.7% against the industry 's decline of 5.7%. More on the Positive CHMP Opinion for RHHBY's Itovebi Therapy The favorable CHMP opinion is supported by findings from Roche's phase III INAVO120 study, which demonstrated a 57% reduction in the risk of disease progression or death (progression-free survival) for patients receiving the Itovebi-based regimen compared with those treated with Pfizer's Ibrance and AstraZeneca's Faslodex alone in the first-line setting. This benefit was consistent across all pre-specified subgroups, including patients with more aggressive disease that had spread to three or more locations. Additionally, the regimen was well tolerated, with no new safety concerns identified. In January 2025, positive top-line results from the final overall survival (OS) analysis of the INAVO120 study were announced, confirming a statistically significant and clinically meaningful survival advantage with the Itovebi-based treatment. Although OS data were still maturing at the time of the primary analysis, a clear favorable trend had already emerged. Full OS results are expected to be presented during an oral session at the 2025 American Society of Clinical Oncology Annual Meeting. Per Roche, PIK3CA mutations, which occur in roughly 40% of HR-positive breast cancers, are associated with more aggressive disease and poorer survival outcomes. This highlights the critical need for early PIK3CA mutation testing before initiating first-line treatment, enabling timely access to effective PI3K-targeted therapies for patients with a less favorable prognosis. The Itovebi-based regimen could redefine the standard of care in this first-line setting, where current treatment options remain limited, pending approval. Apart from the INAVO120 study, Roche is simultaneously evaluating various other combinations of Itovebi in three late-stage studies for treating PIK3CA-mutated, locally advanced or metastatic breast cancer. RHHBY is also planning further clinical investigations in breast cancer and other tumor types, aiming to extend the potential benefits of this targeted therapy to a broader population of patients with PIK3CA mutations. RHHBY's Zacks Rank & Stock to Consider Roche currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Bayer BAYRY, carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. In the past 60 days, estimates for Bayer's earnings per share have increased from $1.19 to $1.25 for 2025. During the same time, earnings per share have increased from $1.28 to $1.31 for 2026. Year to date, shares of Bayer have gained 43.4%. BAYRY's earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%. 7 Best Stocks for the Next 30 Days Just released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers "Most Likely for Early Price Pops." Since 1988, the full list has beaten the market more than 2X over with an average gain of +23.0% per year. So be sure to give these hand picked 7 your immediate attention. See them now >> Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AstraZeneca PLC (AZN): Free Stock Analysis Report Roche Holding AG (RHHBY): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY): Free Stock Analysis Report This article originally published on Zacks Investment Research (
Yahoo
24-05-2025
- Business
- Yahoo
GSK plc (GSK) Stock Rises as FDA Approves Nucala for COPD, CHMP Backs Blenrep for Cancer Treatment
GSK plc (NYSE:GSK) has strengthened its market outlook following major regulatory milestones. The U.S. FDA's recent approval of Nucala for chronic obstructive pulmonary disease (COPD) and a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) for Blenrep in multiple myeloma signal significant expansion in GSK's high-demand therapeutic portfolio. These advances are expected to boost the company's Specialty Medicines segment, which already reported a robust 17% sales increase, and are central to analyst projections of 4.6% annual revenue growth over the next three years. Despite broader market volatility and renewed trade tensions, GSK plc (NYSE:GSK) shares have climbed 4.9% in the past month, outperforming a market that saw a 2.5% weekly decline. This surge reflects growing investor confidence in GSK's innovation pipeline and future earnings potential. The company's fair value is estimated at £16.72 per share, suggesting an 18.6% upside from current levels. Over five years, GSK plc (NYSE:GSK) delivered a 5.42% total shareholder return, underscoring steady long-term growth amid industry challenges. While the stock underperformed the UK Pharmaceuticals sector over the past year, recent product approvals could reinforce GSK's competitive position and drive further gains. While we acknowledge the potential of GSK to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than GSK and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Sign in to access your portfolio
Medscape
23-05-2025
- Health
- Medscape
EMA Changes Azithromycin Use to Combat Antibiotic Resistance
The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended several changes to the way the antibiotic azithromycin is used in the EU, including the removal of certain indications. The recommendations aim to optimize the use of the antibiotic and minimize the development of antimicrobial resistance, CHMP said. CHMP's review and re-evaluation of the benefits and risks of azithromycin medicines given by mouth or IV infusion came at the request of the German Federal Institute for Drugs and Medical Devices. It has led to new changes that include uses of the drug to be refined and harmonized, uses to be discontinued, and a new product warning. The full list of revised uses, found in the published product information, mainly concern upper and lower respiratory tract infections, sexually transmitted diseases, female reproductive system infections, dental infections, and treatment and prevention of types of Mycobacterium avium complex infections in people living with HIV-1. CHMP said that the antibiotic could no longer be used in moderate acne vulgaris, eradication of Helicobacter pylori, and prevention of exacerbations of eosinophilic and noneosinophilic asthma. This is because its effectiveness in these conditions has not been clearly demonstrated, including that its benefits do not outweigh its risks. These indications will be removed from the product information. The committee pointed out that some azithromycin medicines are also approved in the EU for topical use, but that these medicines are out of the scope of the review procedure. Higher Risk for Resistance Azithromycin is included in the World Health Organization (WHO) list of essential medicines but is also classified by the WHO as an antibiotic that carries a higher risk for antimicrobial resistance. It is included in WHO's Watch category (AWaRe classification), so the drug should be prioritized as a key target for prudent use and monitoring. CHMP said that there had been an increased use of azithromycin in recent years. A study commissioned by the EMA and performed by DARWIN EU, which analyzed the prescription of the 141 antibiotics in WHO's Watch category between 2012 and 2021 in France, Germany, Spain, the Netherlands, and United Kingdom, found that azithromycin was among the top five most prescribed antibiotics in the majority of databases assessed, and within the top 10 in all the databases included. Data from the ATLAS and SENTRY databases showed an increasing global prevalence of azithromycin resistance among bacterial strains linked to the approved indications of azithromycin in the EU/European Economic Area. Research has also shown that azithromycin resistance has increased in recent years. A study published last month (April 2025) in Frontiers in Microbiology found that the prevalence of azithromycin resistance in pathogenic bacteria from clinical samples was 22%, and indicated an increase in prevalence after the COVID-19 pandemic, which the study's researchers described as 'a major concern.' CHMP explained that a new warning will also be included in the summary of product characteristics about the importance of clinicians assessing the benefits and the risks, considering the local prevalence of resistance, and deciding when preferred treatment regimens are not indicated. This is based on the fact that azithromycin could favor the development of resistance due to its long-lasting, decreasing levels in plasma and tissues after the end of treatment.
Medscape
23-05-2025
- Health
- Medscape
Blenrep Gets European Nod to Treat Multiple Myeloma
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion for Blenrep (belantamab mafodotin) for the treatment of relapsed or refractory multiple myeloma. The drug is an antibody drug conjugate comprising a humanized IgG1κ monoclonal antibody targeting the B-cell maturation antigen (BCMA), conjugated with a cytotoxic agent, maleimidocaproyl monomethylauristatin F (mcMMAF). Belantamab mafodotin binds to BCMA on the surface of myeloma cells, causing cell cycle arrest and inducing antibody-dependent cellular cytotoxicity. According to the manufacturer, GSK, it is the first such conjugate to be approved and represents a new mechanism of action compared with existing agents. Generally Poor Prognosis Multiple myeloma is a rare and incurable disease of the plasma cells, typically affecting adults older than 60 years of age. First-line therapy is usually with targeted cancer drugs such as lenalidomide or bortezomib in combination with a steroid, sometimes with chemotherapy and a stem cell transplant. Relapses are treated similarly. The disease has a generally poor prognosis and there is a need for novel effective therapies. Blenrep had been designated as an orphan medicine, and the EMA will now review the information to determine whether this can be maintained. CHMP said that two phase 3, randomized, open-label studies had shown that adding Blenrep to standard therapy of either bortezomib and dexamethasone in patients who have received at least one prior therapy, or pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide, prolonged progression-free survival in patients with relapsed or refractory multiple myeloma. Ocular Side Effects Common The safety and tolerability profiles of the Blenrep combinations were broadly consistent with those of the individual agents. The most common side effects with Blenrep include reduced visual acuity, corneal examination abnormalities (including keratopathy), thrombocytopenia, blurred vision, dry eye, foreign-body sensation in eyes, eye pain, photophobia, eye irritation, neutropenia, anemia, and diarrhea. Patients should have an ophthalmic examination, including visual acuity and slit-lamp examination, by an eye care professional before each of the first four doses of Blenrep, and as clinically indicated thereafter. Patients should be encouraged to inform their physicians of any ocular symptoms. The drug will be available as 70 mg or 100 mg powder for concentrate for solution for infusion. It is administered as a 30-minute infusion every 3 or 4 weeks. Treatment should be prescribed by physicians experienced in the treatment of multiple myeloma. Detailed recommendations will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorization has been granted by the European Commission.
