Centessa Pharmaceuticals plc 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. 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.
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- Centessa Pharmaceuticals Receives Fast Track Designation from the U.S. FDA for Serpinpc for Hemophilia B