The U.S. Food and Drug Administration has approved Bayer’s new medication to prevent recurrent strokes. Asundexian will be marketed in the U.S. under the brand name Sunharbo and is the first representative of a new class of drugs targeting factor XIa to receive authorization for use on the U.S. market.
The drug is intended for adult patients following a recent non-cardioembolic ischemic stroke or high-risk transient ischemic attack. It is taken in combination with antiplatelet therapy, and the recommended dose is 50 milligrams once daily.
“Today’s approval represents significant progress for patients and healthcare professionals seeking a new option for secondary stroke prevention,” said Hilton V. Joffe, director of the Division of Cardiology, Hematology, Endocrinology and Nephrology at the Center for Drug Evaluation and Research of the U.S. agency.
What the study results show
The regulator’s decision is based on the phase III OCEANIC-STROKE study, which included 12,327 patients. In the study, asundexian was compared with a placebo in people who had recently experienced a non-cardioembolic ischemic stroke or high-risk transient ischemic attack.
Ischemic stroke was recorded in 6.2 percent of patients taking asundexian, compared with 8.4 percent in the placebo group. This corresponds to a 26 percent relative reduction in risk. The incidence of major bleeding was similar in the two groups, but gastrointestinal bleeding occurred more frequently among patients taking Sunharbo. The most commonly reported adverse reaction was diarrhea.
What the approval means for Bayer
For Bayer, the FDA decision provides a new potential growth driver at a time when the German pharmaceutical group needs new products with significant market potential. The company’s shares temporarily rose 2 percent to €57.78, an annual high, Handelsblatt reported.
The road to approval was not without obstacles. In November 2023, Bayer discontinued a large study of asundexian in patients with atrial fibrillation after the drug showed weaker results than a competing medication. The new approval, however, concerns a different use—reducing the risk of recurrent stroke following a non-cardioembolic ischemic stroke or high-risk transient ischemic attack.
Bayer expects deliveries of Sunharbo in the U.S. to begin in mid- to late November. The drug has already been approved in China, where authorization was granted on October 26, 2026. Applications for use in the European Union and Japan are still under review.