Agios Advances Mitapivat Toward Potential U.S. Accelerated Approval in Sickle Cell Disease Following Pre-sNDA Meeting with FDA
Agios Pharmaceuticals announced plans to pursue accelerated approval from the FDA for mitapivat, an oral pyruvate kinase activator, to treat sickle cell disease. Following a pre-sNDA meeting with the FDA, the company has submitted a proposed confirmatory trial protocol and intends to file the sNDA in the coming months. The accelerated approval path…