Shots:
- The US FDA has approved Agios’ Aqvesme (mitapivat) for the treatment of anemia in adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
- Approval was based on the global P-III (ENERGIZE) and (ENERGIZE-T) studies (n=452), which met all 1EPs and 2EPs, demonstrating significant improvements in hemoglobin, fatigue, and reductions in transfusion burden vs PBO
- Aqvesme will be available in the US in late Jan’26 under a REMS program due to hepatocellular injury risk; mitapivat will continue to be marketed as Pyrukynd for PK deficiency
Ref: Globenewswire | Image: Agios Pharmaceuticals | Press Release
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