The Food and Drug Administration (FDA) has granted Fast Track designation to asundexian for the prevention of stroke and systemic embolism in patients with atrial fibrillation.
Asundexian is an investigational oral Factor XIa (FXIa) inhibitor. According to Bayer, asundexian acts selectively on the coagulation cascade, thereby offering the potential to prevent events without the increased bleeding risk.
The Company is currently enrolling patients in the phase 3 OCEANIC-AF study (ClinicalTrials.gov Identifier: NCT05643573). In OCEANIC-AF, the safety and efficacy of asundexian will be compared with apixaban in patients with atrial fibrillation at risk for stroke.
“This designation provides an opportunity to accelerate the development of asundexian and quickly address current patient needs,” said Christian Rommel, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “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.”
The FDA’s Fast Track designation helps to accelerate the development and review of products for serious and life-threatening conditions where no treatment exists or where the investigational therapy is likely to provide an advantage over currently available treatments.
Asundexian was previously fast tracked for secondary prevention in patients after a noncardioembolic ischemic stroke. The phase 3 OCEANIC-STROKE study (ClinicalTrials.gov Identifier: NCT05686070) will investigate the efficacy and safety of asundexian for prevention of ischemic stroke compared with placebo on top of standard of care antiplatelet therapy in patients after a noncardioembolic ischemic stroke or high-risk transient ischemic attack.
Bayer receives US FDA Fast Track designation for asundexian atrial fibrillation program. News release. May 16, 2023. https://www.businesswire.com/news/home/20230516005400/en/Bayer-Receives-U.S.-FDA-Fast-Track-Designation-for-asundexian-Atrial-Fibrillation-Program.