Look for Drugs and Conditions

Reference pic

Bayer's oral FXIa inhibitor reduced bleeding in patients with atrial fibrillation: Study

DTMT Network

German pharma major Bayer AG has recently announced that its new experimental drug asundexian reduced the bleeding rate by 67% when compared with non-vitamin K antagonist oral anticoagulant apixaban in patients with atrial fibrillation (AF) during trial.

In a statement released recently, Bayer said that it has presented the finding of the study during the 71st Annual Scientific Session of the American College of Cardiology.

The report of the study has been published in the journal Lancet recently, Bayer informed.

Asundexian belongs to a class of anticoagulants called Factor XIa (FXIa) inhibitor is administered orally and has not been approved by any health authority for use in any country, for any indication, the statement by Bayer added.

The data found that both 20 mg and 50 mg doses of asundexian were well-tolerated and resulted in significantly lower rates of bleeding compared with apixaban while achieving almost complete inhibition of FXIa.

The company pointed out that the trial (PACIFIC-AF) is the first head-to-head trial to compare the bleeding risk of an oral FXIa inhibitor vs. a non-vitamin K antagonist oral anticoagulant (NOAC) in patients with AF who are at risk of stroke.

“There is an unmet need for stroke prevention in people with atrial fibrillation,” Prof. Manesh Patel, Chief of the Division of Cardiology and Co-Director of the Heart Center at Duke University said.

“Despite guidelines recommending oral anticoagulation treatment of patients with atrial fibrillation, around 40% of AF patients are either under-treated, receiving a lower dose than is recommended, or not treated at all; and this can leave patients vulnerable to potentially life-changing thrombo-embolic events, such as stroke,” he added.

“The PACIFIC-AF data showed asundexian had significantly less bleeding compared to apixaban in AF patients at risk of stroke, while achieving near complete FXIa inhibition levels, he further added saying that the potential new therapy would mark a much-welcomed advance in patient care.

“Today’s clinical research findings provide additional support for the mechanism and safety profile of asundexian in patients with AF,” Dr Christian Rommel, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Research and Development at Bayer said.

“With our FXI(a) inhibitor program, Bayer is developing innovative, next-generation therapies for patients and families impacted by cardiovascular disease,” he added.

FXIa inhibitors act by specifically targeting a protein involved in pathological thrombus formation but leaving the pathway involved in physiological vessel healing intact, and the drug could have the potential to prevent thrombo-embolic events without a corresponding increase in bleeding risk, Bayer said.


0 Comments
Be first to post your comments

Post your comment

Related Articles

Ad 5