Latest news with #KedrionBiopharma
Cision Canada
05-05-2025
- Health
- Cision Canada
KEDRION CELEBRATES PLASMINOGEN AWARENESS DAY BY HIGHLIGHTING QUEBEC-MADE INNOVATION FOR A RARE DISEASE Français
Laval facility at the heart of global efforts to treat ultra-rare genetic disorder PLGD-1. LAVAL, QC, May 5, 2025 /CNW/ - Kedrion Biopharma, a global biopharmaceutical company, is proud to mark Plasminogen Awareness Day with a special event at its Laval facility, celebrating the development and ongoing production of RYPLAZIM ® (plasminogen, human-tvmh), the world's first and only approved treatment for plasminogen deficiency type 1 (PLGD-1), an ultra-rare genetic disorder. PLGD-1 is a rare genetic disorder caused by a deficiency in plasminogen, a protein essential for breaking down fibrin, a substance involved in blood clotting and tissue healing. Without sufficient plasminogen, fibrin can accumulate abnormally on all mucous membranes throughout the body, leading to painful and potentially serious complications, most commonly affecting the inner lining of the eyelidsbut potentially affecting all organs with mucous membranes. Left untreated, PLGD-1 has the potential to cause vision loss, breathing difficulties, and chronic inflammation, significantly impairing quality of life and, in severe cases, becoming life-threatening. Originally developed by Quebec-based biopharmaceutical company Prometic, which was acquired by Kedrion, RYPLAZIM is now manufactured at Kedrion's Laval facility and represents a medical and scientific breakthrough for patients affected by this debilitating condition, which impacts approximately 1.6 individuals per million worldwide. The treatment is currently approved for use in the United States. Kedrion is actively working with Canadian health authorities to seek broader recognition and eventual registration of the therapy in Canada. The scientific breakthrough behind this therapy is credited to a team of Quebec scientists led by Pierre Laurin, a visionary in the biotechnology sector, who pioneered the development of a novel plasma protein purification system. This innovation made it possible to isolate rare plasma proteins—such as plasminogen—that are typically lost in standard plasma fractionation processes. Personally committed to the cause of rare diseases, he dedicated himself to creating tangible solutions for patients who are too often left without effective treatment options. While RYPLAZIM is not yet approved for general use in Canada, patients in Quebec may access the therapy on a case-by-case basis through Health Canada's Special Access Program. In the province, distribution is coordinated through Héma-Québec. This exception-based access remains essential for the small number of individuals living with PLGD-1, offering a critical treatment option where no alternative is available. The Laval event is part of a global series of activities taking place simultaneously in Fort Lee (United States) and Bolognana (Italy), underscoring Kedrion's international commitment to addressing rare diseases. The Mayor of Laval, Stéphane Boyer, attended the event alongside patient advocates, medical experts, and members of the Kedrion team. " At Kedrion, we believe that every patient deserves access to life-changing therapies, no matter how rare their condition may be. The work accomplished here in Laval is a powerful example of Quebec's scientific leadership and the global impact of our innovations," said Sophie Larabée, Site Leader at Kedrion Biopharma. Kedrion continues to collaborate with patient foundations and regulatory authorities to raise awareness, improve access, and ensure that innovative therapies like RYPLAZIM reach those who need them, here in Canada and around the world. Among these partners is the Plasminogen Deficiency Foundation, established in 2020–2021, which plays a vital role in supporting individuals living with PLGD globally, regardless of geography. About Kedrion Biopharma Kedrion Biopharma is a global biopharmaceutical company specializing in the collection and fractionation of human plasma to produce and distribute therapies for rare and serious diseases. With a strong presence in North America, Europe, and emerging markets, Kedrion is committed to improving the lives of patients worldwide through the development and delivery of plasma-derived treatments. Its Laval facility plays a critical role in the company's innovation ecosystem, having led the development of RYPLAZIM—the first and only approved treatment for plasminogen deficiency type 1 (PLGD-1).
Yahoo
21-03-2025
- Business
- Yahoo
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 "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 - Media Contact: Jennifer Donegan, US Communications Lead, 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 View original content to download multimedia: SOURCE Kedrion Biopharma
