Bayer won U.S. FDA approval for a first-in-class stroke blood thinner

The Food and Drug Administration (FDA) has approved Bayer's novel drug, to be sold under the brand name Sunharbo, for the reduction of stroke recurrence. This marks the introduction of a new class of medications capable of preventing blood clots more safely compared to traditional blood thinners, which are often avoided in this context due to an increased risk of bleeding.

Sunharbo functions by inhibiting a protein called XIa, a mechanism believed to effectively halt the development of detrimental clots without raising the risk of bleeding. A Phase 3 trial involving individuals who had previously experienced a stroke and were already on standard stroke treatments revealed that 8.4% of patients in the placebo group suffered a secondary stroke, whereas only 6.2% of those administered Sunharbo encountered a recurrence, resulting in a 26% reduction in risk.

Alternatively, this data can be interpreted as requiring the treatment of 53 patients over the course of one year to avert a single recurrent stroke. For further details, proceed to STAT+.