Abelacimab Receives Fast Track Designation from FDA for Prevention of Stroke, Systemic Embolism in Patients with Atrial Fibrillation

The US Food and Drug Administration (FDA) on September 8, granted fast track designation for abelacimab (Anthos Therapeutics) for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF), according to the manufacturer.

In July 2022, the FDA also assigned fast track designation for abelacimab for cancer-associated thrombosis.

The dual-acting, fully human monoclonal antibody selectively targets both factor XI and factor XIa with high affinity. Abelacimab can be administered intravenously for immediate inhibition of factor XI activity and subsequently used monthly to maintain nearly complete inhibition in a chronic setting, according to Anthos.

“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, professor of Medicine and Clinical Pharmacology, Sidney Kimmel Medical College, Thomas Jefferson University, William Wikoff Smith Chair in Cardiovascular Research, Lankenau Heart Institute, in a press release.

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.

“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,” continued Kowey. “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.”

Real-world studies have shown that adherence to current treatments is “less than ideal” for many patients, including those with AF and cancer-associated thrombosis, according to chief medical officer of Anthos Therapeutics, Dan Bloomfield, MD. “This non-adherence may be associated with an increased risk of stroke. With one in four people dying from thromboembolic events globally, the need to do better is urgent,” added Bloomfield in the release.

The FDA grants fast track designation 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 possibly future accelerated priority review and accelerated approval.