FDA grants fast track designation to Bayer’s new drug for preventing stroke in AFib patients
Asundexian, a new investigational drug from Bayer, is now one step closer to being approved by the U.S. Food and Drug Administration (FDA) to treat atrial fibrillation (AFib).
The company announced Tuesday, May 16, that asundexian for the prevention of stroke and systemic embolism in AFib patients has been granted the FDA’s Fast Track Designation, expediting the review process. The drug was previously granted the fast track designation to prevent strokes among patients after a non-cardioembolic ischemic stroke in 2022.
“The second Fast Track Designation for asundexian emphasizes the medical need to prevent stroke and systemic embolism in people diagnosed with AFib,” Christian Rommel, a member of the executive committee of Bayer AG’s Pharmaceutical Division and head of research and development, said in a prepared statement. “This designation provides an opportunity to accelerate the development of asundexian and quickly address current patient needs. Despite significant advances in treatment, potential concerns of bleeding risks remain at the forefront of thrombosis management. Asundexian is currently investigated as a candidate in an entirely new class of antithrombotic treatment options aiming to selectively modulate coagulation, address patients with concerns of bleeding, and focus on indications where current anticoagulation is not used.”
As things stand now, asundexian has not been approved to be used in any part of the world for any indication. It is currently the subject of two multicenter Phase III studies—the OCEANIC-AF trial and OCEANIC-STROKE trial—focused on its safety and efficacy.
Asundexian vs. apixaban among AFib patients
In April 2022, a study presented at ACC.22 and published in The Lancet found that daily doses of asundexian were linked to “lower rates of bleeding compared” compared to apixaban among patients presenting with AFib. A total of 753 patients participated in the study, including 249 treated with 20 mg of asundexian, 254 treated with 50 mg of asundexian and another 250 treated with apixaban. The full study can be read here.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.