FDA approves 1st-of-its-kind stroke drug

The FDA has approved Bayer’s Sunharbo (asundexian), the first factor XIa inhibitor, after a phase 3 trial found the drug reduced the risk of ischemic stroke by 26% compared with placebo over a median treatment period of 14.2 months. The approval rests on OCEANIC-STROKE, a phase 3, placebo-controlled trial of 12,327 adults with a recent […] The post FDA approves 1st-of-its-kind stroke drug appeared first on Becker's Hospital Review | Healthcare News & Analysis.

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