Kedrion Expands Ryplazim Distribution Network for PLGD-1 Patients

, /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, [email protected] 

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 INFORMATION
CONTRAINDICATIONS:

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

SOURCE Kedrion Biopharma