· The OCEANIC-AF (Atrial Fibrillation) study is one of the Phase III OCEANIC clinical research programs, which plans to recruit more than 27,000 patients across over 40 countries/regions.
· Asundexian, which is under development as a potential therapy for improving stroke prevention, represents a new type of thrombus management approach, aiming to maintain efficacy without increasing the risk of bleeding.
On May 16, 2023, Bayer announced that its investigational drug asundexian (BAY2433334) received Fast Track designation from the U.S. Food and Drug Administration (FDA) as a potential therapy for the prevention of stroke and systemic embolism in patients with atrial fibrillation. This follows the drug's first FDA Fast Track designation in 2022 for secondary prevention in patients with non-cardioembolic ischemic stroke.
Asundexian is not yet approved or marketed in any country. It is an oral Factor XIa (FXIa) inhibitor taken once daily, currently in clinical trials to evaluate its potential to reduce thrombosis without altering the body's bleeding response, thereby preventing thrombotic events.
Fast Track Designation aims to facilitate the development and expedited review of candidate drugs for the treatment of serious diseases, allowing patients to access important new therapies as soon as possible. Candidate drugs that receive Fast Track Designation have the opportunity for more frequent interactions with the U.S. FDA to discuss development plans and, if relevant criteria are met, may qualify for accelerated approval and priority review.
Christian Rommel, Ph.D., Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Research and Development, said: "The second Fast Track designation for asundexian underscores the medical need to prevent stroke and systemic embolism in patients with atrial fibrillation. This designation provides an opportunity to accelerate the development of asundexian and rapidly address the current needs of patients. While significant progress has been made in this therapeutic area, the potential risk of bleeding remains a primary concern in thrombosis management. Asundexian is currently being investigated as a candidate for a new class of antithrombotic therapy, aiming to selectively modulate coagulation to address the issue of bleeding risk in patients while also exploring indications not yet covered by existing anticoagulants."
It is estimated that up to 40% of patients do not receive direct oral anticoagulant therapy or are under-treated. 1The reason is that patients' concerns about the risk of bleeding outweighed their need for thrombosis prevention.
References
1. E, Wolff A, Lip GY, Lane DA. Optimising stroke prevention in patients with atrial fibrillation: application of the GRASP-AF audit tool in a UK general practice cohort. Br J Gen Pract. 2015 Jan;65(630):e16-23. doi: 10.3399/bjgp15X683113. PMID: 25548312; PMCID: PMC4276003.