Centessa Pharmaceuticals Receives U.S. FDA Fast Track Designation for SerpinPC Hemophilia B
Monday, May 22, 2023
Centessa Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SerpinPC, an investigational novel inhibitor of activated protein C (APC) being developed for the treatment of hemophilia B, with or without inhibitors.
SerpinPC has the potential to be a first-in-class subcutaneously administered therapy with a differentiated safety profile for persons with hemophilia B, subject to review and approval. This designation is important recognition of SerpinPC’s novel mechanism of action and underscores the critical need for new treatment options for persons with hemophilia B.
SerpinPC is a subcutaneously administered novel inhibitor of APC being developed as a potential treatment for hemophilia, regardless of severity or inhibitor status, and which may also be developed to prevent bleeding associated with other bleeding disorders.
SerpinPC is an investigational agent that has not been approved by the FDA or any other regulatory authority.
