Abelacimab receives FDA fast track designation for stroke prevention in AF
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Anthos Therapeutics announced abelacimab, a fully human monoclonal antibody inhibiting factor XI, received fast track designation from the FDA for an indication to prevent stroke and systemic embolism in patients with atrial fibrillation.
As Healio previously reported, abelacimab received an FDA fast track designation in July for an indication to treat cancer-associated thrombosis.
“Although there have been important advances in anticoagulation treatment in the last 60 years, there remains a need for new agents that protect patients from having a stroke while offering a lower risk of bleeding than currently available anticoagulants. This is especially true for the elderly, patients with renal or hepatic impairment, and those with a prior history of bleeding,” Cardiology Today Arrhythmia Disorders Section Editor Peter R. Kowey, MD, FACC, FHRS, FAHA, professor of medicine and clinical pharmacology at Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia and the William Wikoff Smith Chair in Cardiovascular Research at the Lankenau Heart Institute in Wynnewood, Pennsylvania, said in a press release. “Factor XI inhibitors have the potential to uncouple the processes that lead to thrombosis from those that are involved in creating normal clots. By doing so, the hope is that this new class of anticoagulants will be at least as effective as current treatments — and have an enhanced safety profile. An alternative administration method and less frequent dosing will facilitate the care of patients who, for a variety of reasons, struggle with daily pill taking.”
Abelacimab has been shown to inhibit both factor XI and its active form, factor XIa, and is the first factor XI inhibitor to have a phase 3 trial in which patients have been enrolled, according to the release.
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.
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