LEVERKUSEN (dpa-AFX) - Bayer AG (BAYN.DE, BYR.L) announced that the U.S. Food and Drug Administration (FDA) has approved SUNHARBO (asundexian) in combination with antiplatelet therapy to reduce the risk of stroke in adults with recent non-cardioembolic ischemic stroke (NIHSS ?15) or high-risk transient ischemic attack (TIA).
SUNHARBO is a once-daily, first-in-class, oral Factor XIa inhibitor for secondary stroke prevention. The recommended dosage is 50 mg. SUNHARBO was approved based on results from the pivotal Phase 3 OCEANIC-STROKE study.
Reducing the risk of a stroke after an initial event is often referred to as secondary stroke prevention. According to the company's estimates, approximately 795,000 people in the U.S. experience a stroke each year. Of these, approximately 87% are ischemic, and 23% are recurrent. Approximately one in 10 stroke survivors will have another stroke within one year, and one in five will have another stroke within five years.
Supportive Trial Details
In the Phase 3 OCEANIC-STROKE study, SUNHARBO was studied compared to placebo in adults after a non-cardioembolic ischemic stroke (NIHSS ?15) or high-risk transient ischemic attack, both in combination with antiplatelet therapy.
The Phase 3 OCEANIC-STROKE study randomised 12,327 patients to receive either SUNHARBO (N=6,162) or placebo (N=6,165). The mean age at enrollment was 68 years. The primary endpoint was time to first occurrence of ischemic stroke.
Key Trial FindingsAccording to the company, SUNHARBO significantly reduced ischemic stroke by 26% compared to placebo (6.2% vs. 8.4%).
The rate of major bleeding was similar between SUNHARBO and placebo (1.6 versus 1.5 events per 100 patient-years).
SUNHARBO also significantly reduced the risk of all strokes (ischemic and hemorrhagic) versus placebo (6.6% vs. 8.8%).
SUNHARBO reduced the composite of cardiovascular death, myocardial infarction (MI) or stroke (9.2% vs. 11.1%). This secondary endpoint was primarily driven by reduced ischemic stroke.
The most frequently reported (>3%) adverse reaction in the SUNHARBO-treated patients was diarrhoea (3.4% vs 2.8% in the SUNHARBO and placebo groups, respectively). The rate of gastrointestinal bleeding was higher in the SUNHARBO group compared to placebo (2.7 vs 2.1 per 100 patient-years).
Road AheadSUNHARBO is the first approved medicine in the U.S. to target Factor XIa.Bayer anticipates that SUNHARBO will begin shipping in mid-to-late November and will become available for hospitals and pharmacies to order across the U.S. shortly thereafter.
CEO Quote'We are proud to bring the first approved Factor XIa inhibitor to market in the U.S. for secondary stroke prevention,' said Nelson Ambrogio, President of Bayer U.S. Pharmaceuticals.
Other Regulatory DetailsAs of November 2026, SUNHARBO is currently under review by the European Medicines Agency (EMA) and Japan's Ministry of Health, Labour and Welfare (MHLW). China's National Medical Products Administration (NMPA) approved SUNHARBO on October 26, 2026.
Stock Performance
BAYN.DE has traded between 26.17 Euros and 56.62 Euros over the last year. The stock closed Monday's trade at 56.62 Euros, down 1.87%.
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