The Food and Drug Administration approved Bayer’s asundexian, sold as Sunharbo, to reduce the risk of another stroke, Bayer said on Nov. 10 in its announcement. The asundexian FDA approval makes it the first Factor XIa inhibitor cleared in the United States.
The approval covers a 50 mg tablet taken once a day alongside antiplatelet therapy. It is for adults who recently had a non-cardioembolic ischemic stroke with a stroke-scale score of 15 or lower, or a high-risk transient ischemic attack.
What the OCEANIC-STROKE Trial Found
The approval rests on OCEANIC-STROKE, a Phase III trial that randomized 12,327 patients in a placebo-controlled, double-blind design. Bayer reports that asundexian reduced ischemic stroke by 26% compared with antiplatelet therapy alone. Major bleeding, measured by the International Society on Thrombosis and Haemostasis definition, was similar between the two groups, the company says.
A 26% reduction is a relative figure. How many patients it spares depends on the baseline rate of second strokes in the trial, and a reader who wants the absolute numbers will find them in the trial paper and the FDA label. Bayer sponsored the trial, and the efficacy and bleeding claims come from the company.
Why Secondary Stroke Prevention Matters
Bayer cites about 795,000 strokes a year in the United States, which is about 2,180 a day, a calculation from the annual figure. The company says about 1 in 10 survivors of a non-cardioembolic stroke has another within a year and about 1 in 5 within five years. The class matters because Factor XIa sits in the clotting pathway, and drugs aimed at it were developed to prevent clots without the bleeding that comes with most blood thinners. Whether Sunharbo delivers that in practice depends on the bleeding data behind the label, since the company’s release describes the major-bleeding result only as similar. Christian Rommel, global head of research and development for Bayer’s pharmaceuticals division, called the approval “a bold step forward in post-stroke care.”
Approvals Outside the United States
The FDA reviewed the application under Priority Review. China’s drug regulator approved asundexian on Oct. 26, Bayer said, and the company says applications are under review in other markets. Bayer has not announced a U.S. price or launch date for Sunharbo.
