Archive: Miriam Guterland / Wikimedia Commons / CC BY-SA 3.0
WASHINGTON – The U.S. Food and Drug Administration on Monday approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa inhibitor cleared in the United States, to reduce the risk of another stroke in certain adults. The approval went to Bayer HealthCare Pharmaceuticals Inc. of Whippany, N.J.
Sunharbo is approved for use together with antiplatelet therapy in adults after a recent mild-to-moderate stroke caused by a clot that did not start in the heart, or after a high-risk transient ischemic attack, often called a mini-stroke. It is not approved for stroke prevention in people with atrial fibrillation.
The FDA said the drug’s effectiveness was shown in OCEANIC-STROKE, a randomized, double-blind, placebo-controlled phase 3 study of 12,327 adults. Patients were assigned to Sunharbo or placebo within 72 hours of symptoms, and both groups also received antiplatelet therapy. Taking Sunharbo 50 mg once daily reduced the risk of ischemic stroke by 26% compared with placebo over a median treatment of 14.2 months.
Bleeding is the main risk. The FDA said the overall rate of major bleeding was similar to placebo, but it was higher with Sunharbo in patients older than 75 and during the first 90 days of treatment, and gastrointestinal bleeding was more common. The most frequent side effect, in 3% or more of patients, was diarrhea. The drug is not recommended with certain medicines that can weaken it, such as carbamazepine, or in people with moderate or severe liver impairment, and should be paused at least 24 hours before elective surgery.
The agency granted the drug Fast Track and Priority Review status. Stroke is a leading cause of disability and death in the United States, and survivors face a risk of another one, the FDA’s Hylton Joffe said, calling the approval “a meaningful advance for patients and health care providers seeking a new option for secondary stroke prevention.”
Why it matters: it opens a new drug class for stroke prevention and gives a New Jersey-based drugmaker a major U.S. approval. Still unknown: the price, when the drug will reach pharmacies, and how insurers will cover it. The FDA’s announcement does not say.
File photo: a Bayer pharmaceutical site in Berlin. It is not tied to the approval.
JBizNews Desk | Washington
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