Citing lack of efficacy evidence, the FDA rejected Cytokinetics’ heart failure hopeful omecamtiv mecarbil in a Tuesday evening decision.
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The U.S. Food and Drug Administration’s panel of outside experts did not lend its support to Cytokinetics Inc.’s heart drug, citing insufficient data on safety and efficacy.
U.S. Food and Drug Administration staff reviewers on Friday identified safety and efficacy concerns about Cytokinetics Inc.’s heart drug, according to briefing documents published on the agency’s website.