Agios Pharmaceuticals (NASDAQ: AGIO) announced that, following a successful pre-SNDA meeting with the U.S. Food and Drug Administration (FDA), the company is actively advancing the accelerated approval process for its candidate drug mitapivat for the treatment of sickle cell disease (SCD).
Agios Pharmaceuticals (NASDAQ: AGIO) announced that, following a successful pre-SNDA meeting with the U.S. Food and Drug Administration (FDA), the company is actively advancing the accelerated approval process for its candidate drug mitapivat for the treatment of sickle cell disease (SCD).
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This key meeting clarified a feasible pathway for seeking accelerated approval of Mitapivat in the United States, marking an important step forward for the drug in addressing this serious hematological disease. The company plans to submit a marketing application to the FDA as soon as possible based on existing clinical data.
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