Agios Pharmaceuticals granted priority review for mitapivat sNDA
Agios Pharmaceuticals announced that the FDA has accepted its supplemental new drug application for mitapivat, an oral pyruvate kinase activator, in sickle cell disease with a priority review. The Prescription Drug User Fee Act goal date for this sNDA, submitted under the FDA's accelerated approval pathway, is November 1.
Agios Pharmaceuticals announced that the FDA has accepted its supplemental new drug application for mitapivat, an oral pyruvate kinase activator, in sickle cell disease with a priority review.
The Prescription Drug User Fee Act goal date for this sNDA, submitted under the FDA's accelerated approval pathway, is November 1.