FDA Approves Bayer's Asundexian to Prevent Recurrent Strokes
The FDA has approved Bayer's asundexian, a new anticoagulant branded as Sunharbo, to prevent recurrent ischemic strokes. Clinical trials showed a 26 percent reduction in stroke risk without a significant increase in major bleeding.
The U.S. Food and Drug Administration (FDA) has approved Bayer's new medication, asundexian, marketed as Sunharbo, for the prevention of recurrent stroke. Asundexian is the first in a new class of anticoagulants and has demonstrated in a large clinical trial a 26 percent reduction in the risk of recurrent ischemic stroke without a significant increase in major bleeding events.
The medication is intended for patients who have suffered a non-cardioembolic stroke or a high-risk transient ischemic attack. The approval is based on the OCEANIC-STROKE study, published in the New England Journal of Medicine, which involved 12,327 participants. Participants were divided into two groups: one receiving the new once-daily oral drug and the other receiving a placebo, alongside standard antiplatelet therapy such as aspirin.
Clinical Trial Results and Findings
Results indicated that 6.2 percent of patients receiving asundexian experienced a recurrent ischemic stroke, compared to 8.4 percent in the placebo group. This represents a relative risk reduction of 26 percent, preventing approximately 22 strokes per 1,000 patients over the study period. Prof. Ronen Leker, head of the stroke unit at Hadassah Medical Center, noted that the efficacy was observed across various patient subgroups, including those with small vessel disease.
While the overall rate of major bleeding showed no statistically significant difference between the drug and placebo groups, the FDA noted an increased risk for patients over 75 and during the first 90 days of treatment. Experts emphasize that the new drug serves as an additional layer of prevention alongside lifestyle modifications and existing medications, rather than a complete replacement.
