The Food and Drug Administration on Monday approved Bayer’s drug to reduce the recurrence of stroke, making available the first in a novel class of medications that hold the promise of preventing blood clots more safely. The drug, asundexian, will be sold under the brand name Sunharbo in 50 milligram tablets and inhibits the clotting protein factor XIa, a mechanism thought to stop the formation of harmful clots without increasing the risk of bleeding that limits the use of existing blood thinners in this setting. The FDA cleared it for use alongside antiplatelet therapy in adults after a recent mild to moderate non-cardioembolic ischemic stroke or a high risk transient ischemic attack, and granted it Fast Track and Priority Review designations. It is not approved for stroke prevention in patients with atrial fibrillation.
In the Phase 3 OCEANIC-STROKE trial, which enrolled 12,327 adults who had already had a stroke or a high risk mini stroke and were taking common stroke treatments, Sunharbo cut the risk of ischemic stroke by 26 percent against placebo over a median treatment of 14.2 months, the FDA said; 6.2 percent of patients who took Sunharbo experienced a secondary stroke, against 8.4 percent on placebo, and STAT calculated that 53 patients need to be treated for one year for one recurrent stroke to be prevented. The overall rate of major bleeding was similar between the groups, the FDA said, but was higher on Sunharbo in patients older than 75 and during the first 90 days of treatment, and gastrointestinal bleeding was more common. China approved asundexian under the same Sunharbo brand name on October 26, the first approval of a factor XIa inhibitor anywhere in the world.