The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Centessa Pharmaceuticals’ SerpinPC, an investigational novel inhibitor of activated protein C (APC) being developed for the treatment of hemophilia B, with or without inhibitors.
“We are pleased with the FDA’s decision to grant Fast Track designation for SerpinPC as we continue to advance the PRESent registrational studies for SerpinPC in hemophilia B,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa.
“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. We believe 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.”
According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fulfill an unmet medical need.
A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval, Priority Review, or Rolling Review.
