FDA Approves Bayer’s Sunharbo, the First Factor XIa Inhibitor, to Help Prevent Repeat Strokes

The Food and Drug Administration on Monday, Nov. 9, approved Bayer’s Sunharbo to reduce the risk of another stroke in certain adults, the agency said. The drug, known scientifically as asundexian, is the first factor XIa inhibitor approved by the FDA.

Related: Aiming for Systolic Pressure Below 120 Did Not Significantly Cut Heart Events in Adults With Type 2 Diabetes, Trial Finds.

Who the drug is for

Sunharbo is a 50 mg tablet taken with antiplatelet therapy, the FDA said. It is approved for adults after a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack, often called a mini-stroke. A non-cardioembolic stroke is caused by a clot that did not originate in the heart.

The drug is not approved for stroke prevention in patients with atrial fibrillation, according to the FDA. It stumbled in a key atrial fibrillation experiment, BioPharma Dive reported.

“Today’s approval represents a meaningful advance for patients and health care providers seeking a new option for secondary stroke prevention,” Dr. Hylton V. Joffe, an FDA drug-review office director, said.

What the trial found

The approval rested on OCEANIC-STROKE, a phase 3 study that enrolled 12,327 adults, the FDA said. Patients were assigned to Sunharbo or a placebo within 72 hours of symptom onset, and both groups also received antiplatelet therapy.

Once-daily Sunharbo reduced the risk of ischemic stroke by 26% compared with placebo over a median treatment of 14.2 months, the agency said. Secondary strokes occurred in 6.2% of patients on Sunharbo and 8.4% of those on placebo, STAT reported. Fifty-three patients would need treatment for one year to prevent one recurrent stroke, according to STAT.

Bleeding and other risks

The overall rate of major bleeding was similar between the two groups, the FDA said. Major bleeding increased with Sunharbo in patients older than 75 and during the first 90 days of treatment, the agency said. Gastrointestinal bleeding was more common with the drug. The most frequently reported adverse reaction was diarrhea.

The FDA said Sunharbo is not recommended for patients with moderate or severe liver impairment. It should be withheld at least 24 hours before elective surgery or invasive procedures, and for at least 24 hours after clot-dissolving treatment for acute stroke.

Price and competition

A 30-day supply will carry a list price of $748.50, a Bayer spokesperson told BioPharma Dive. Sebastian Guth, president of Bayer U.S., told the outlet that stroke neurologists will be a “very important part” of the drug’s early rollout.

The U.S. decision followed approval in China, Sunharbo’s first market, pharmaphorum reported. Bristol Myers Squibb and Johnson & Johnson are jointly developing a rival drug, milvexian, which has suffered setbacks in clinical testing, according to BioPharma Dive.

More than 795,000 people in the U.S. have a stroke each year, and about a quarter have had one before, health authorities estimate, BioPharma Dive reported. More medical coverage is on our health and science hub and our health news page.

Sources

• FDA: FDA Approves First Factor XIa Inhibitor to Help Prevent Stroke in Certain Adults at High Risk
• BioPharma Dive: Bayer wins FDA nod for a new kind of blood thinner
• STAT: FDA approves novel Bayer drug to reduce recurrence of stroke
• pharmaphorum: Bayer gets first approval for stroke drug asundexian

About the reporter: Theo Lin is an AI reporter covering technology, AI and science for The Boston Report. This article was produced with AI under our editorial policy. Read our AI and media disclosure.