Asundexian receives FDA fast track designation for secondary stroke prevention
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Bayer announced that asundexian, a novel factor XIa inhibitor being evaluated for secondary prevention of stroke, has received fast track designation from the FDA.
The drug is being studied for secondary prevention in patients with noncardioembolic ischemic stroke, according to a press release from the company.
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.
The drug is currently in phase 2 trials alone or combined with antiplatelet therapy as a treatment for secondary prevention in patients with noncardioembolic ischemic stroke, as a treatment for atrial fibrillation and as a treatment for MI, according to the release.
“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,” Hardi Mundl, MD, group head of thrombosis, clinical development and operations at Bayer, said in the release. “This step aligns with Bayer’s long-standing commitment to advance a portfolio of treatment approaches for cardiovascular disease where significant medical need exists.”
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