U.S. FDA Grants Priority Review to Agios’ sNDA for Mitapivat in Sickle Cell Disease
Agios Pharmaceuticals announced that the FDA has accepted its supplemental New Drug Application for mitapivat, an oral pyruvate kinase activator aimed at treating sickle cell disease, granting it Priority Review status with a PDUFA goal date of November 1, 2026. If approved, mitapivat would be the first oral PK activator for this indication, built …