BAYRY - Bayer's stroke prevention drug asundexian gets 2nd FDA fast track status

2023-05-16 06:24:25 ET

• The U.S. Food and Drug Administration (FDA) granted fast track designation to Bayer's ( OTCPK:BAYRY ) ( OTCPK:BAYZF ) asundexian as potential therapy to prevent stroke and systemic embolism in people with atrial fibrillation (AF).
• Asundexian (BAY2433334) had previously received the FDA's fast track tag in February 2022 for preventing stroke in patients after a non-cardioembolic ischemic stroke.
• The German conglomerate said asundexian is being evaluated as a potential once-daily oral Factor XIa (FXIa) inhibitor in thrombosis prevention with the goal to reduce clot formation while leaving the body's ability to respond to bleeding intact. The drug is being explored in a clinical trial program called OCEANIC.
• "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," said Christian Rommel, member of the executive committee of Bayer's Pharmaceutical Division and head of Research and Development.
• AF is an irregular heart rhythm (arrhythmia) which could lead to blood clots in the heart.

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