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Tuesday, Oct 3, 2023

FDA Fast-Tracks Amgen Heart Drug

The U.S. Food and Drug Administration has fast-tracked Amgen Inc.’s heart failure drug, the Thousand Oaks company said Friday. The drug, omecamtiv mecarbil, also known as cardiac myotrope, is part of a collaboration between the biotech giant and San Francisco-based Cytokinetics Inc., a biopharmaceutical company focused on treating muscle debilitation. It is currently in a Phase 3 clinical trial program. After that, a new drug application will be submitted to the FDA. Fast-track designation can potentially expedite a drug’s review if it addresses an unmet medical need, Amgen said in a statement. “This fast-track designation represents an important milestone in the development of omecamtiv mecarbil,” Dr. David Reese, vice president of research and development at Amgen, said in a statement. “Today, half of heart failure patients will die within five years of diagnosis, underscoring the urgent need for new therapies for this grievous condition.” Shares of Amgen (AMGN) closed Friday up $1.49, or a fraction of a percent, to $234.82 on the Nasdaq.

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