FDA Approves Bayer's Sunharbo, the First Factor XIa Inhibitor, to Help Prevent a Second Stroke

The U.S. Food and Drug Administration approved Sunharbo (asundexian) on November 9, a Bayer tablet that is the first drug of its kind, a Factor XIa inhibitor, cleared to help prevent stroke. It is for adults who have recently had a mild-to-moderate ischemic stroke not caused by a clot from the heart, or a high-risk transient ischemic attack (TIA), and it is taken together with antiplatelet therapy.

"Stroke is a leading cause of disability and death in the United States." — Hylton V. Joffe, M.D., FDA

The agency called the approval a meaningful advance for patients and health care providers.

What the trial found

Approval rests on OCEANIC-STROKE, a randomized, double-blind, placebo-controlled Phase 3 study:

• 12,327 adults with a recent non-cardioembolic ischemic stroke or high-risk TIA
• Treatment began within 72 hours of symptoms, and everyone also received antiplatelet therapy
• A 50 mg daily dose reduced the risk of ischemic stroke by 26% compared with placebo
• Median treatment lasted 14.2 months

Safety and limits

Overall major bleeding was similar to placebo, but the FDA notes it rose in people over 75 and during the first 90 days of treatment. Gastrointestinal bleeding was more common than with placebo, and diarrhea was the most frequent side effect. The drug is not approved for stroke prevention in people with atrial fibrillation, and it is not recommended with certain interacting medicines or in moderate or severe liver impairment.

Why it matters

Surviving a first stroke leaves many people at real risk of another. A new class of preventive medicine gives doctors another option alongside existing treatments, with the FDA having granted the application Fast Track and Priority Review status. Decisions about whether it suits a particular patient remain a matter for that patient and their doctor.