RegulatoryOfficial

FDA approves Bayer's Sunharbo, first factor XIa inhibitor, for secondary stroke prevention

🇺🇸 FDA · Mon 09 Nov 2026

Asundexian 50 mg tablets are cleared alongside antiplatelet therapy after a recent non-cardioembolic ischaemic stroke or high-risk TIA, with bleeding data shaping the label.

The US Food and Drug Administration has approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa inhibitor to reach the market. It is indicated, in combination with antiplatelet therapy, to reduce stroke risk in adults after a recent mild-to-moderate non-cardioembolic ischaemic stroke or a high-risk transient ischaemic attack (TIA). The marketing authorisation was granted to Bayer HealthCare Pharmaceuticals Inc. of Whippany, New Jersey. The product had Fast Track and Priority Review designations.

Efficacy rests on OCEANIC-STROKE, a multicentre, randomised, double-blind, placebo-controlled phase 3 trial in 12,327 adults. Participants had a recent non-cardioembolic ischaemic stroke (NIH Stroke Scale of 15 or below) or a high-risk TIA, and were randomised within 72 hours of symptom onset. Everyone received antiplatelet therapy. Over a median treatment duration of 14.2 months, Sunharbo 50 mg once daily cut the risk of ischaemic stroke by 26% against placebo.

On safety, the FDA reports that overall major bleeding rates were similar to placebo. However, bleeding increased with Sunharbo in patients over 75 and during the first 90 days of treatment, and gastrointestinal bleeding was more common than with placebo. Diarrhoea was the most frequent adverse reaction, seen in 3% or more of treated patients.

The agency also set out several use restrictions. Co-administration with combined P-gp and strong CYP3A4 inducers, such as carbamazepine, is not recommended because they may reduce effectiveness. The drug is not recommended in moderate or severe hepatic impairment. It should be withheld for at least 24 hours before elective surgery or invasive procedures, and for at least 24 hours after thrombolysis for acute ischaemic stroke. Sunharbo is not approved for stroke prevention in patients with atrial fibrillation.

What it means for your team

  • PV teams should prepare for a new-class anticoagulant: the bleeding profile, especially in over-75s, in the first 90 days and in the gastrointestinal tract, is a likely focus of routine surveillance and signal detection.
  • Regulatory and labelling teams should note the specific restrictions: CYP3A4/P-gp inducer interaction, hepatic impairment, peri-procedural and post-thrombolysis hold periods, and the exclusion of atrial fibrillation.
  • Quality and medical information teams may need to field queries on the 50 mg once-daily dose, and on drug interactions and procedural timing.
  • Market-access teams should track how the approved indication, limited to adjunctive use with antiplatelet therapy after non-cardioembolic stroke or high-risk TIA, defines the eligible population.

Official source: FDA ↗

Article written by VigiEye from the official source (FDA). AI-assisted; check the source before acting.

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