The Food and Drug Administration (FDA) has granted Fast Track designation to asundexian (BAY2433334) as a potential treatment for secondary prevention in patients with a noncardioembolic ischemic stroke.
Asundexian is an investigational oral Factor XIa (FXIa) inhibitor. The Company is currently evaluating asundexian as monotherapy or in combination with antiplatelet therapy in the PACIFIC phase 2 clinical trial program, which consists of three phase 2b studies in over 4000 patients with 1 of the following conditions: atrial fibrillation (PACIFIC-AF [ClinicalTrials.gov Identifier: NCT04218266]), recent noncardioembolic ischemic stroke (PACIFIC-STROKE [ClinicalTrials.gov Identifier: NCT04304508]), or recent myocardial infarction (PACIFIC-AMI [ClinicalTrials.gov Identifier: NCT04304534]).
“We are pleased that asundexian has received Fast Track Designation from the FDA, underscoring the urgent need for additional effective therapies to treat secondary stroke prevention,” said Hardi Mundl, MD, group head thrombosis, clinical development and operations, Bayer.
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.
Bayer receives FDA Fast Track designation for asundexian stroke program. News release. Bayer. Accessed February 10, 2022. https://www.businesswire.com/news/home/20220210005616/en/Bayer-Receives-FDA-Fast-Track-Designation-for-asundexian-Stroke-Program