Asundexian gains fast track designation for stroke prevention in patients with AF
Click Here to Manage Email Alerts
Bayer announced the FDA has granted fast track designation for asundexian — a once-daily oral factor XIa inhibitor — for the prevention of stroke and systemic embolism in patients with atrial fibrillation.
Asundexian has not been approved for any indication by any health authority in any country and is currently being evaluated as a potential option for thrombosis prevention with no increased bleeding risk, according to a company press release.
In February 2022, asundexian for secondary stroke prevention received fast track designation from the FDA.
As Healio previously reported, asundexian on top of dual antiplatelet therapy successfully reduced factor XIa activity after stroke, with no excess bleeding risk.
The results of the phase 2 PACIFIC-AF trial indicated that patients with AF requiring stroke prevention experienced less bleeding while taking asundexian compared with apixaban (Eliquis, Bristol Myers Squibb/Pfizer), according to findings presented at the 2022 European Society of Cardiology Congress. However, a recent secondary analysis of PACIFIC-AF trial presented at the 2023 International Stroke Conference showed that asundexian may be effective for the secondary prevention of stroke in patients with stroke of atherosclerotic origin, but not those with small subcortical infarcts.
“The second fast track designation for asundexian emphasizes the medical need to prevent stroke and systemic embolism in people diagnosed with atrial fibrillation,” Christian Rommel, member of the executive committee of Bayer’s pharmaceutical division and head of research and development, said in the release. “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.”
The fast track designation is granted to therapies with the potential to fill unmet needs of patients with serious medical conditions. It includes the ability for the developer to have more frequent interactions with the agency, and potentially future accelerated priority review and accelerated approval.
Collapse
Click Here to Manage Email Alerts