FDA Expected to Announce Decision on Mitapivat for Sickle Cell Disease

The U.S. Food and Drug Administration (FDA) has a Prescription Drug User Fee Act (PDUFA) goal date of November 1, 2026, for its decision on Agios Pharmaceuticals' supplemental New Drug Application (sNDA) for mitapivat in sickle cell disease. The application was filed under the accelerated approval pathway and granted Priority Review. Mitapivat, an oral pyruvate kinase activator, aims to be the first oral PK activator for this patient population.