Posted by Michael Wonder on 08 Jul 2026
US FDA grants priority review to Agios’ sNDA for mitapivat in sickle cell disease
7 July 2026 - Agios Pharmaceuticals today announced that the US FDA has accepted its supplemental new drug application for mitapivat, an oral pyruvate kinase activator, in sickle cell disease with a priority review.
The PDUFA goal date for this supplemental new drug application, submitted under the FDA’s accelerated approval pathway, is 1 November 2026.
