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FDA approves Bayer's asundexian (Sunharbo) for secondary stroke prevention
The FDA on Monday approved Bayer's Sunharbo (asundexian) 50 mg, the first Factor XIa inhibitor, with antiplatelet therapy after a recent non-cardioembolic ischemic stroke or high-risk TIA.
The U.S. Food and Drug Administration on Monday approved Bayer HealthCare Pharmaceuticals' Sunharbo (asundexian) 50 milligram tablets, a once-daily Factor XIa inhibitor, to be used with antiplatelet therapy to lower stroke risk in adults after a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack2. Reuters also reported the approval1.
The agency said it is the first approved Factor XIa inhibitor for that use2.
Effectiveness was shown in OCEANIC-STROKE, a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial of 12,327 adults assigned to Sunharbo or placebo within 72 hours of symptom onset, all also on antiplatelet therapy2. Over a median 14.2 months, once-daily 50 mg Sunharbo reduced ischemic stroke risk by 26% versus placebo, the FDA said2.
Hylton V. Joffe of FDA's Center for Drug Evaluation and Research said stroke remains a leading cause of disability and death and that survivors remain at risk of another stroke2. The FDA granted Fast Track and Priority Review and said Sunharbo is not approved for stroke prevention in atrial fibrillation2. The label says to withhold the drug at least 24 hours before elective surgery or invasive procedures and for at least 24 hours after thrombolysis for acute ischemic stroke2.
The agency said overall major bleeding was similar to placebo but was higher with Sunharbo in patients older than 75 and during the first 90 days of treatment, that gastrointestinal bleeding was more common, and that diarrhea was the most frequently reported adverse reaction, occurring in 3% or more of treated patients2. Combined P-gp and strong CYP3A4 inducers are not recommended, nor is use in moderate or severe hepatic impairment2.
Not medical advice.
