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.”