Agios Pharmaceuticals, Inc. (AGIO) Monday said its Phase 3 ENERGIZE-T study of mitapivat in adults with transfusion-dependent thalassemia achieved its primary endpoint of transfusion reduction response.
Thalassemia is an inherited blood disorder that causes the body to have less hemoglobin than normal.
In the Phase 3 ENERGIZE-T study, patients were randomized to receive either mitapivat or placebo. 30.4 percent patients treated with mitapivat showed a statistically significant reduction in transfusion burden compared to 12.6 percent patients in the placebo arm. Treatment with mitapivat also demonstrated a statistically significant reduction in additional measures of transfusion reduction response compared to placebo.
Agios plans to submit a marketing application for mitapivat in Thalassemia in the U.S. by the end of 2024. The company also intends to submit marketing applications in Europe and the Gulf Cooperation Council (GCC) countries.
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