FDA Approves Kedrion's Bolognana Facility for Production of First and Only Treatment for PLGD-1, Ryplazim®

FORT LEE, N.J., Nov. 19, 2024 /PRNewswire/ -- Kedrion Biopharma Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the company's manufacturing facility in Bolognana, Italy, to produce RYPLAZIM®. This plasma-derived human plasminogen is indicated for treating patients with plasminogen deficiency type 1 (PLGD-1), a rare and challenging chronic disease. RYPLAZIM® offers new hope for those affected by PLGD-1.

PLGD-1 primarily manifests through the development of abnormal extra-vascular fibrin-rich, ligneous lesions on mucosal surfaces throughout the body. The most commonly observed lesions occur in the eye (ligneous conjunctivitis), but they can also appear in the ears, mouth, central nervous system, skin, and respiratory, gastrointestinal, and genitourinary tracts. These lesions can lead to severe and life-altering consequences, including vision and hearing loss, airway obstruction, infertility and hydrocephalus.

This FDA approval is a significant milestone for both Kedrion and the global PLGD-1 community, enabling an expansion of RYPLAZIM® production capacity. This enhancement ensures that this crucial treatment can reach more PLGD-1 patients in the United States and worldwide.

RYPLAZIM® exemplifies Kedrion's commitment to addressing unmet medical needs in rare diseases. As the first and only FDA-approved therapy specifically for PLGD-1, RYPLAZIM® represents a major advancement in patient care, addressing the root cause of PLGD-1 and offering patients the possibility of a near-normal life.

"The FDA's approval of our Bolognana facility is a pivotal moment for our company, and I want to thank all employees worldwide who contributed to this achievement," said Bob Rossilli, CCO, Global Business and US General Manager. "This expanded capacity for RYPLAZIM® means we can provide treatment for more patients with PLGD-1. Offering a product like RYPLAZIM® to patients in need is truly a privilege."

Rebecca Bialas MD, Co-founder and Chair of The Plasminogen Deficiency Foundation, "With increased awareness of PLGD-1, the expanded capacity of RYPLAZIM® ensures we are better equipped to meet the growing demand. This means more patients who receive the correct diagnosis can be confident they will get the treatment they so desperately deserve and need. This is an exciting time for the PLGD-1 community, marking a significant event in our collective journey towards better health."

This accomplishment highlights Kedrion's dedication to scientific excellence and patient-focused innovation. Recognizing the profound impact of PLGD-1 on individuals and families, this milestone is the first of several steps to increase RYPLAZIM®'s capacity.

For more information about RYPLAZIM® and Kedrion Biopharma Inc., please visit [ Ryplazim | Envision a brighter future ].

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.

CONTACT: Jennifer Bayliss, U.S. Lead, [email protected] 

SOURCE Kedrion Biopharma