The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of Anthos Therapeutics’ abelacimab for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF).
This represents the second Fast Track designation Anthos has received in less than two months, with the FDA also assigning this designation to abelacimab for cancer-associated thrombosis (CAT) in July 2022. Earlier this year, abelacimab also became the first-ever Factor XI inhibitor to begin enrolling patients in Phase 3 trials.
“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,” said Peter Kowey, MD, FACC, FHRS, FAHA, professor of Medicine and Clinical Pharmacology at Sidney Kimmel Medical College at Thomas Jefferson University and the William Wikoff Smith Chair in Cardiovascular Research at the Lankenau Heart Institute.
“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.”
“The blood clot patient community is actively monitoring the development of Factor XI inhibitors, such as abelacimab, and the role they may play for many patients today who are either not being treated with an anticoagulant or are being undertreated due to a fear of potential bleeding, poor adherence or other complications,” said Leslie Lake, volunteer president of the National Blood Clot Alliance. “We are hopeful these new generation Factor XI inhibitors will help to significantly improve patient outcomes and reduce the incidence of morbidity and mortality we still see too often.”
“Real-world evidence has shown that adherence to current therapies is less than ideal for many patients, including those with atrial fibrillation and cancer associated thrombosis. This non-adherence may be associated with an increased risk of stroke,” said Dan Bloomfield, MD, FACC, FAHA, chief medical officer, Anthos Therapeutics. “With one in four people dying from thromboembolic events globally, the need to do better is urgent. As a company, we remain highly committed to working closely with the FDA to bring once-monthly abelacimab to patients in need.”
The Fast Track Designation process is designed to facilitate the development and expedite the review of treatments for serious medical conditions, thereby addressing unmet medical needs. Drugs that are included in this program may be eligible for more frequent interactions with the FDA to discuss the development path, and if the program criteria are met, eligibility for a potential Rolling Review, Accelerated Approval, and Priority Review.