The FDA approved Agios Pharmaceuticals’ mitapivat under the brand name Aqvesme for use in thalassemia, marking a regulatory win after a three‑month delay and missed deadline. Mitapivat’s approval expands therapeutic options for hemoglobinopathy patients with limited disease‑modifying treatments. The approval follows Agios’ submission package and clinical evidence showing hemoglobin and transfusion‑related benefits in targeted thalassemia populations. Agios will proceed with commercial launch planning and market access activities. This approval strengthens Agios’ hematology portfolio and may affect competitive dynamics in rare anemia therapies.