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2h ago

FDA Approves Sunharbo, First Factor XIa Anticoagulant, to Prevent Repeat Strokes

Late‑stage trials found the drug reduced recurrent non‑cardioembolic ischemic strokes without raising overall major bleeding risk, shifting questions to coverage and real‑world use.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
The 120 metres high Bayer Cross, logo of German pharmaceutical and chemical maker Bayer AG, consisting of 1710 LED glass bulbs is seen outside the industrial park "Chempark" of the chemical industry in Leverkusen, Germany, September 23, 2023. REUTERS/Wolfgang Rattay/File Photo
Second strokes are more likely to be disabling, said Johnson’s neurologist, Dr. Andrew Russman, the medical director of the Comprehensive Stroke Center at the Cleveland Clinic,

Overview

  • The FDA approved Sunharbo (asundexian) on Monday, Nov. 9, 2026, as a once‑daily medicine to reduce the risk of another stroke in adults after a recent non‑cardioembolic ischemic stroke or a high‑risk transient ischemic attack.
  • Sunharbo is the first approved drug that targets Factor XIa, a clotting protein thought to cut clot formation while sparing the body’s normal bleeding control.
  • A phase 3 trial of more than 12,000 people found Sunharbo lowered recurrent ischemic stroke risk by about 26% when added to standard antiplatelet therapy and reduced stroke severity in some measures.
  • Overall major bleeding rates were similar to placebo but were higher in people older than 75 and during the first 90 days of treatment, and gastrointestinal bleeding occurred more often with Sunharbo.
  • Bayer set a 30‑day list price of $748.50 and described the drug as practice changing, but its market success will depend on insurer coverage, physician adoption, and results from rival Factor XIa programs now in late‑stage testing.