Agios Pharmaceuticals Inc. (AGIO) announced that the U.S. Food and Drug Administration has approved AQVESME (mitapivat), an oral pyruvate kinase (PK) activator, for the treatment of anemia in adults with alpha- or beta-thalassemia.
With this approval, AQVESME becomes the only FDA-approved medicine indicated for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia, the company said in a statement.
Due to the AQVESME REMS program, mitapivat will be marketed under the brand name AQVESME in the United States specifically for the thalassemia indication. For PK deficiency, mitapivat will continue to be marketed as PYRUKYND in the U.S., which does not require a REMS program. Outside the U.S., mitapivat will retain the PYRUKYND brand name for both PK deficiency and thalassemia indications in regions where it is approved, as well as in those currently under regulatory review.
Agios expects AQVESME to be commercially available in the United States in late January 2026, following the implementation of the AQVESME REMS program.
AGIO closed Tuesday's regular trading at $24.59, down $0.36 or 1.44%. In after-hours trading the stock was slightly lower at $24.58.
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