The FDA approved Agios Pharmaceuticals’ mitapivat for the treatment of thalassemia under the brand name Aqvesme, following a three‑month review delay. The approval provides Agios with a newly authorized therapy for a rare hemoglobinopathy and marks a commercial milestone for the company’s pipeline. The decision expands treatment options for patients with thalassemia and may influence competitive positioning among companies developing therapies for hemoglobin disorders. Agios will move toward product launch and commercialization efforts targeting clinicians and specialist treatment centers.