Drugs

Bayer’s Asundexian Cuts Recurrent Stroke Risk in Phase 3

Bayer is reporting that its investigational oral anticoagulant asundexian reduced the risk of recurrent ischemic stroke by 26% in patients who had recently experienced a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack, without increasing major bleeding. The findings are from the company’s just-reported pivotal Phase 3 OCEANIC-STROKE trial.

The global study enrolled 12,327 patients and compared once-daily asundexian 50 mg with placebo, with both given on top of standard antiplatelet therapy. Patients treated with asundexian were significantly less likely to experience a subsequent ischemic stroke than those receiving placebo, according to Bayer.

Importantly, it says, the reduction in recurrent stroke was not accompanied by an increase in major bleeding as defined by the International Society on Thrombosis and Hemostasis. Major bleeding occurred in 1.9% of patients in the asundexian group compared with 1.7% in the placebo arm, a difference that was not statistically significant. Rates of minor bleeding, hemorrhagic stroke, symptomatic intracranial hemorrhage, and fatal bleeding were similar between groups.

Bayer says that OCEANIC-STROKE is notable as the first completed Phase 3 trial of a Factor XIa inhibitor to demonstrate superiority over placebo in preventing recurrent ischemic stroke. The inhibitors are designed to interfere with thrombosis while preserving much of normal hemostasis, a strategy intended to lower bleeding risk compared with traditional anticoagulants, it says.

Bayer says it plans to submit the OCEANIC-STROKE data to regulatory authorities to seek marketing approval for asundexian. The drug has already received fast track designation from FDA for stroke prevention following non-cardioembolic ischemic stroke.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome