Bayer Receives FDA Fast-Track Designation for Next-Generation Anticoagulant

Bayer has received Fast-Track designation from the U.S Food and Drug Administration (FDA) for its investigational anticoagulant asundexian (BAY2433334). Asundexian is an oral factor XIa inhibitor currently under phase 2 trials for potential secondary thrombosis prevention in patients with non-cardioembolic ischemic stroke, atrial fibrillation, or recent myocardial infarction.

To receive Fast Track designation, a drug must treat a serious condition and fulfill an unmet medical need. If a drug gains Fast Track status, it is eligible for more frequent communications and meetings with the FDA to quickly resolve issues and expedite the availability of the drug to patients.

Factor XIa inhibitors are next-generation anticoagulants that affect the coagulation cascade at a different location than warfarin or direct oral anticoagulants (DOACs). In doing so, experts believe that these experimental agents may effectively prevent thrombosis with less risk of bleeding. Similarly to most DOACs, which directly bind to factor Xa active sites and block its action, asundexian binds directly to factor XIa and blocks its effects on coagulation.

By targeting a different coagulation factor, asundexian essentially inhibits the contact (intrinsic) pathway of the coagulation cascade with minimal effects on the tissue factor (extrinsic) pathway. Given that the intrinsic pathway is activated by the presence of endothelial irritants, such as atherosclerotic plaques, and the extrinsic pathway responds to external damage to blood vessels, drugs that inhibit factors in the intrinsic pathway offer a novel mechanism for preventing pathological thrombosis with less effect on physiological hemostasis.

Three phase 2 trials, PACIFIC-AF, PACIFIC-STROKE, and PACIFIC-AMI, are currently evaluating proper dosing and safety of asundexian in over 4,000 patients with atrial fibrillation, non-cardioembolic ischemic stroke, or recent myocardial infarction. Bayer is developing asundexian as monotherapy or in combination with antiplatelet therapy.

Milvexian, developed by Bristol Myers Squibb and Janssen Pharmaceuticals, is another factor XIa inhibitor in phase 2 trials.