Posted by Michael Wonder on 08 Dec 2025
Agios provides update on US sNDA for mitapivat in thalassaemia
8 December 2025 - Agios Pharmaceuticals today announced that the US FDA has not yet issued a regulatory decision on the supplemental new drug application for mitapivat for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia and that the supplemental new drug application remains under active review.
The PDUFA goal date issued by the FDA was 7 December 2025.
