- Kedrion Biopharma’s facility in Bolognana, Italy, has received FDA approval to manufacture RYPLAZIM.
- RYPLAZIM treats plasminogen deficiency type 1 (PLGD-1), a rare disease causing debilitating lesions.
Kedrion Biopharma has announced that its manufacturing facility in Bolognana, Italy, has been approved by the U.S. Food and Drug Administration (FDA) to produce RYPLAZIM, a plasma-derived treatment for plasminogen deficiency type 1 (PLGD-1). This rare chronic condition primarily causes abnormal fibrin-rich lesions on mucosal surfaces, which can result in severe complications such as vision and hearing loss, airway obstruction, and infertility.
RYPLAZIM is the first FDA-approved therapy to directly address the root cause of PLGD-1, offering patients a treatment that can potentially restore normal function. With the new approval, Kedrion aims to enhance global access to this vital medication.
“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,” said Bob Rossilli, Chief Commercial Officer and General Manager for Kedrion’s US operations.
The increased production capacity is expected to address growing demand within the global PLGD-1 community, ensuring that more patients have access to this life-changing treatment. Rebecca Bialas, MD, Co-founder and Chair of The Plasminogen Deficiency Foundation, commented, “The expanded capacity of RYPLAZIM ensures we are better equipped to meet the growing demand. This is an exciting time for the PLGD-1 community.”
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