Bayer's novel drug for stroke recurrence wins FDA approval

Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.

The Food and Drug Administration on Monday approved Bayer’s drug to reduce recurrence of stroke, making available the first in a novel class of medications that hold the promise of preventing blood clots more safely.

Many blood thinners aren’t used in this setting due to their increased risk of bleeding. But Bayer’s drug, which will be sold under the brand name Sunharbo, inhibits a protein called XIa, utilizing a mechanism that’s thought to stop the formation of bad clots without increasing the risk of bleeding.

In a Phase 3 trial that enrolled people who had already had a stroke and were taking common stroke treatments, 8.4% of participants who took placebo experienced a secondary stroke, while 6.2% of patients who took Sunharbo experienced one, translating into a 26% risk reduction. Another way to look at the data is that in one year, 53 patients need to be treated for one recurrent stroke to be prevented.

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