Kedrion Biopharma Inc. has received FDA approval for its manufacturing facility in Bolognana, Italy, to produce RYPLAZIM®, the only FDA-approved treatment for plasminogen deficiency type 1 (PLGD-1). This approval marks a significant milestone, expanding production capacity to meet the increasing global demand for this critical therapy.
PLGD-1 is a rare chronic disease characterized by the development of abnormal, extra-vascular, fibrin-rich lesions on mucosal surfaces throughout the body. These ligneous lesions commonly manifest in the eyes (ligneous conjunctivitis) but can also appear in the ears, mouth, central nervous system, skin, respiratory, gastrointestinal, and genitourinary tracts. If left untreated, these lesions can lead to severe complications, including vision and hearing loss, airway obstruction, infertility, and hydrocephalus.
Impact of Increased RYPLAZIM® Production
The FDA's approval of Kedrion's Bolognana facility is poised to significantly impact the PLGD-1 community. With increased production capacity, more patients will have access to RYPLAZIM®, addressing a critical unmet need in the treatment of this rare disease. According to 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."
RYPLAZIM®: A Targeted Treatment for PLGD-1
RYPLAZIM®, a plasma-derived human plasminogen, is designed to address the underlying cause of PLGD-1 by replenishing plasminogen levels in affected individuals. This targeted approach aims to prevent the formation of fibrin-rich lesions and alleviate the associated symptoms, offering patients the potential for a near-normal life. As Bob Rossilli, CCO, Global Business and US General Manager stated, "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."
Kedrion's Commitment to Rare Disease Treatment
This accomplishment underscores Kedrion's commitment to addressing unmet medical needs in rare diseases. Kedrion Biopharma specializes in the research, development, production, and commercialization of plasma-derived therapeutic products for treating and preventing serious diseases and disorders. Their portfolio includes 38 life-saving products distributed in over 100 countries.
