FDA approves Bayer’s Sunharbo, first Factor XIa drug to lower stroke recurrence
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The U.S. Food and Drug Administration on Monday approved Bayer’s Sunharbo to reduce the recurrence of stroke, making it the first drug in a new class that inhibits Factor XIa. The mechanism is meant to block harmful clots without the extra bleeding risk that keeps many conventional blood thinners out of this use.
In a Phase 3 trial of people who had already had a stroke and were on common stroke treatments, 8.4% of those on placebo had a secondary stroke versus 6.2% on Sunharbo — a 26% relative risk reduction. Put another way, treating about 53 patients for one year prevents one recurrent stroke. Further reporting on the approval sits behind STAT+’s paywall.
Continue in the app — vote & join in ➔Source: STAT News · via ahirlevel.hu