Posted by Michael Wonder on 10 Jan 2025
FDA accepts Agios’ supplemental new drug application for Pyrukynd (mitapivat) in adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
8 January 2025 - Agios Pharmaceuticals today announced that the US FDA accepted the company’s supplemental new drug application for Pyrukynd (mitapivat) for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia.
The review classification for this application is standard and the PDUFA goal date is 7 September 2025.
