Kedrion Expands Ryplazim Distribution Network for PLGD-1 Patients
FORT LEE, N.J., March 21, 2025 /PRNewswire/ -- Kedrion Biopharma Inc. expands the distribution network for Ryplazim, a plasma-derived human plasminogen indicated for treating patients with plasminogen deficiency type 1 (PLGD-1). This expansion ensures timely access to this vital medication for patients across the US. PLGD-1 is a serious condition causing abnormal fibrin-rich lesions on mucosal surfaces, potentially leading to severe consequences like vision and hearing loss, airway obstruction, and infertility. Ryplazim, the only FDA approved therapy for PLGD-1 patients, offers an important treatment option.
The recent FDA approval of the technology transfer and manufacturing capacity expansion of Ryplazim has enabled Kedrion to broaden its limited distribution network due to the increase of supply. This crucial step means more patients can have access to this treatment. The expanded network now includes a new distribution partner and two new specialty pharmacies.
CuraScript SD a provider of comprehensive distribution solutions, joins existing partners FFF Enterprises and The Alliance Pharmacy in distributing Ryplazim to patients with PLGD-1.
CVS Health and Soleo Health have been added to the list of specialty pharmacies carrying Ryplazim, increasing access points for patients. These pharmacies join Nufactor, enhancing the network to ensure wider availability.
This collaborative effort underscores Kedrion's commitment to improving patient care and broadening access to essential therapies.
To learn more about accessing Ryplazim and its potential benefits, please visit www.Ryplazim.com.
"The FDA's approval of the tech transfer and capacity expansion enables us to manufacture greater volumes of Ryplazim. We are focused on educating healthcare providers on identifying and diagnosing PLGD-1 patients. Once diagnosed, a strong infrastructure is essential to ensure timely product delivery and an improvement in care for patients.
Our goal is to ensure that every patient has reliable access to therapy they may need for the rest of their life. This distribution network is a significant step toward making that goal a reality." - said Bob Rossilli, CCO, Global Business and US General Manager.
This enhanced distribution network is designed to ensure that patients diagnosed with PLGD-1 can receive treatment promptly and efficiently. Learn more about Kedrion Biopharma's commitment to patient care by visiting Kedrion Biopharma - Keep Life Flowing - kedrion.us
Media Contact: Jennifer Donegan, US Communications Lead, j.donegan@kedrion.com
Kedrion Biopharma is an international biopharmaceutical company specializing in the research and development, production, and commercialization of plasma-derived therapeutic products for use in treating and preventing serious diseases, disorders, and conditions like plasminogen deficiency, hereditary factor X deficiency, and hemophilia. Its portfolio of 38 life-saving products is distributed in over 100 countries.
INDICATIONS AND USAGE
RYPLAZIM® (plasminogen, human-tvmh) is a plasma-derived human plasminogen indicated for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia).
IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS:
RYPLAZIM is contraindicated in patients with known hypersensitivity to plasminogen or other components of RYPLAZIM.
WARNINGS AND PRECAUTIONS:
Bleeding: RYPLAZIM administration may lead to bleeding at active mucosal disease-related lesion sites or worsen active bleeding not related to disease lesions. Discontinue RYPLAZIM if serious bleeding occurs. Monitor patients during and for 4 hours after infusion when administering RYPLAZIM to patients with bleeding diatheses and patients taking anticoagulants, antiplatelet drugs, or other agents which may interfere with normal coagulation.
Tissue Sloughing: Respiratory distress due to tissue sloughing may occur in patients with mucosal lesions in the tracheobronchial tree following RYPLAZIM administration. Please monitor appropriately.
Transmission of Infectious Agents: RYPLAZIM is made from human plasma and therefore carries a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob Disease (CJD) agent.
Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, may occur with RYPLAZIM. If symptoms occur, discontinue RYPLAZIM and administer appropriate treatment.
Neutralizing Antibodies: Neutralizing antibodies (inhibitors) may develop, although they were not observed in clinical trials. If clinical efficacy is not maintained (e.g., development of new or recurrent lesions), determine plasminogen activity trough levels in plasma.
Laboratory Abnormalities: Patients receiving RYPLAZIM may have elevated blood levels of D-dimer. D-dimer levels will lack interpretability in patients being screened for venous thromboembolism (VTE).
ADVERSE REACTIONS:
The most frequent (incidence ≥ 10%) adverse reactions in clinical trials were abdominal pain, bloating, nausea, fatigue, extremity pain, hemorrhage, constipation, dry mouth, headache, dizziness, arthralgia, and back pain.
To report SUSPECTED ADVERSE REACTIONS, contact KEDRION at 1-855-353-7466 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
View original content to download multimedia:https://www.prnewswire.com/news-releases/kedrion-expands-ryplazim-distribution-network-for-plgd-1-patients-302408132.html
SOURCE Kedrion Biopharma
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Miami Herald
36 minutes ago
- Miami Herald
Positive Interim 2-Year Data from enVVeno Medical's VenoValve Pivotal Study to be Presented Today at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting
Interim two-year follow-up data from 42 subjects in the VenoValve pivotal trial show sustained clinical improvement and continued patient benefit at 24 months compared to baseline 83% of subjects maintained a clinically meaningful benefit with a 3 or more point improvement in Revised Venous Clinical Severity Score (rVCSS) 9.1 point average rVCSS improvement among the clinically meaningful benefit cohort Subjects experienced a median 74% improvement in leg pain Interim follow-up data indicate sustained improvements across all venous-specific quality-of-life (QoL) indicators A decision from the U.S. Food and Drug Administration (FDA) on the VenoValve is anticipated in the second half of 2025 Company to host live webcast with presenting Principal Investigator, today, June 6th at 11:20 AM ET / 10:20 AM CT - Access the Webcast Here IRVINE, CA / ACCESS Newswire / June 6, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that interim two-year follow-up data on 42 subjects from the 75 person VenoValve U.S. pivotal trial will be presented today by lead enroller Dr. Cassius Iyad Ochoa Chaar, at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting (VAM25) being held June 4-7, 2025 in New Orleans, LA. Additionally, the Company announced it will host a live webcast to discuss these interim results today, Friday, June 6th at 11:20 AM ET / 10:20 AM CT (details below). Key interim two-year follow-up data being presented at VAM25 include: 83.3% of subjects (n=35/42) maintained a clinically meaningful benefit, defined as an improvement of 3 or more points in the revised Venous Clinical Severity Score (rVCSS).9.1 point average rVCSS improvement among the responder cohort.A median 74% improvement in leg pain, as measured by the Visual Analog Scale (VAS).Wound healing outcomes in 17 subjects with 25 ulcers showed that 60% of ulcers healed completely, 24% decreased in size, and 16% increased in outcomes also demonstrated sustained improvements across all venous specific QoL indicators (VEINES-QoL/Sym).Among the subjects (n=30), a 100% valve patency rate. All values were calculated comparing each patient's baseline levels to the reported values at the patient's 24-month visit. The Revised Venous Clinical Severity Score (rVCSS) is a clinically validated scoring system used to track the progression or regression of venous diseases. "These interim two-year follow-up data demonstrate substantial and sustained improvement across all effectiveness endpoints at two years. This is extremely encouraging, especially when you consider that all the patients enrolled in the study had severe CVI and failed all other treatment options," said Robert Berman, enVVeno Medical's Chief Executive Officer. "Despite attempts over many decades, nobody has been able to create an effective treatment for severe CVI caused by malfunctioning valves in the deep veins of the leg. The VenoValve has the potential to change the treatment paradigm for deep venous CVI, both for the millions of patients suffering from severe CVI and the thousands of vascular surgeons who have been waiting for an effective treatment option." Dr. Cassius Iyad Ochoa Chaar, who is the Associate Professor of Surgery, Division of Vascular Surgery and Endovascular Therapy, Yale School of Medicine, will present the abstract titled, "Patients with Deep Venous Reflux Continue to Experience Clinical Improvement 2-year after Implantation of the VenoValve" today at VAM 2025. The VenoValve is a potential first-in-class, surgical replacement venous valve for patients with severe deep venous CVI. The Company estimates that there are approximately 2.5 million potential new patients each year in the U.S. that could be candidates for the VenoValve. The Company has submitted a pre-market authorization (PMA) application for the VenoValve to the U.S. Food and Drug Administration (FDA), with a decision anticipated in the second half of 2025. Webcast Details The Company will host a webcast presentation to discuss the results for investors, analysts and other interested parties today, June 6, 2025, at 11:20 AM ET / 10:20 AM CT. Joining enVVeno management for the event will be Dr. Chaar. The live webcast will be accessible on the Events page of the enVVeno website, and will be archived for 90 days. About CVI Severe, deep venous Chronic Venous Insufficiency (CVI) is a debilitating disease that is most often caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. When valves inside of the veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase (venous hypertension). Symptoms of severe CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as sleeping, bathing, dressing, and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence. Estimates indicate that CVI costs the U.S. healthcare system in excess of $4 billion each year. About enVVeno Medical Corporation enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. The Company's lead product, the VenoValve®, is a first-in-class surgical replacement venous valve being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe®. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs. The VenoValve is currently being evaluated in the VenoValve U.S. pivotal study and the Company is currently performing the final testing necessary to seek approval for the pivotal trial for enVVe. Cautionary Note on Forward-Looking Statements This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results and timing (may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law. INVESTOR CONTACT:Jenene Thomas, JTC Team, LLCNVNO@ 824-0775 MEDIA CONTACT:Glenn Silver, FINN 818-8198 SOURCE: enVVeno Medical Corporation
Miami Herald
37 minutes ago
- Miami Herald
Jaguar Health to Conduct Fireside Chat June 10 Regarding Company's Efforts to Further its Orphan Disease Development Programs as Part of Lytham Partners' Spring 2025 Spotlight Series
Click here to register SAN FRANCISCO, CA / ACCESS Newswire / June 6, 2025 / Jaguar Health, Inc.(NASDAQ:JAGX) today announced that Lisa Conte, the company's founder, president and CEO, will participate in a virtual fireside chat at 9:00 AM Eastern on Tuesday, June 10, 2025, as part of Lytham Partners' spring 2025 Spotlight Series. The discussion will focus on Jaguar's ongoing efforts to further its orphan disease development programs. Participation Instructions for Jaguar Health's Virtual Fireside Chat During Lytham Partners Spring 2025 Spotlight Series When: Tuesday, June 10, 2025 from 9:00 - 10:00 AM Eastern Where: Online (Click Here). The fireside chat will also be available for replay following the event. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health, visit Napo Pharmaceuticals, visit Napo Therapeutics, visit Magdalena Biosciences, visit Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that Jaguar management will participate in a virtual fireside chat June 10, 2025 as part of Lytham Partners' spring 2025 Spotlight Series. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact: hello@ SOURCE: Jaguar Health, Inc.
Miami Herald
38 minutes ago
- Miami Herald
JBA AI Earns FDA SaMD Recognition
A New Era of Accessible Health Monitoring GARDEN GROVE, CALIFORNIA / ACCESS Newswire / June 9, 2025 / JBA AI, the flagship health-tech division under AQ Pharmaceuticals, Inc. and JBA Brands, proudly announces several major global milestones in its mission to make preventive healthcare more accessible, intelligent, and affordable. JBA AI has been officially recognized by the United States Food and Drug Administration (FDA) as a Software as a Medical Device (SaMD). In addition, the platform has now received Class B Medical Device approval from Vietnam's Ministry of Health. These achievements affirm the platform's safety, clinical effectiveness, and international credibility. The JBA AI mobile application is already available globally for Android users and will soon be released on iOS. It enables contactless, non-invasive vital signs monitoring directly through smartphones or tablets. In just 60 seconds, the app delivers insights on over nine key health metrics. These include heart rate, heart rate variability, blood oxygen saturation, respiratory rate, stress index, and estimated glucose and blood pressure trends. This is achieved using AI-powered facial signal analysis through camera-based remote photoplethysmography technology. Expanding its impact even further, JBA AI has partnered with one of Vietnam's largest financial institutions, which serves more than 30 millions members. Together, they are preparing to launch JBA AI nationwide, making preventive health monitoring more accessible through a trusted and widespread digital network. "JBA AI is more than a health app - it's a certified medical device. Recognized by both the FDA and Vietnam's Ministry of Health," said Tracy Trang Nguyen, founder and CEO of JBA AI. "We're proud to deliver trusted, clinically guided tools for daily health monitoring worldwide." Nguyen is a Vietnamese American engineer and wellness industry leader who developed JBA AI after surviving cancer. Her personal health journey inspired her to combine advanced artificial intelligence with affordable wellness solutions. Under her leadership, JBA AI complements other products within the JBA Brands portfolio, such as GlucoTrojan, Joint Revive Fucoidan, and Vegan Collagen, to form a fully integrated health ecosystem. JBA AI is already gaining traction and is starting to expand into pharmacies, corporate wellness programs, public health campaigns, and family clinics across the United States, Vietnam, and other countries. The platform's franchise-ready model supports rapid local deployment while keeping costs low and impact high. It is designed to help people monitor their health in real-time, without the need for needles, wearable devices or clinic visits. JBA AI is currently welcoming franchisees, affiliates, and institutional partners to help bring this technology to communities around the world. Whether at home or in partnership with healthcare providers, JBA AI is redefining preventive care through data-driven technology and a compassionate approach to well-being. Contact Information Catherine Marino Marketing Managercat@ 714 903 1009 SOURCE: AQP One, Inc. press release
