Anthos Therapeutics Abelacimab received FDA fast track designation

Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational Factor XI inhibitor, abelacimab, for the treatment of thrombosis associated with cancer. The company will also be announcing this important milestone today at a session of the ongoing 2022 Congress of the International Society on Thrombosis and Haemostasis (ISTH) Congress in London, UK.

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.

Venous Thromboembolism (VTE), including both deep vein thrombosis and pulmonary embolism, is the second most prevalent cause of death in patients with cancer, second only to the disease itself.1 However, treatment of Cancer Associated Thrombosis (CAT) can be challenging because the currently available anticoagulants used to treat VTE can have an increased risk of bleeding.2,3

“We believe that abelacimab has the potential to provide patients with cancer associated thrombosis an enhanced safety profile and overall low risk of bleeding, without sacrificing any efficacy of currently available agents. This unmet need is particularly true in patients with gastrointestinal/genitourinary (GI/GU) cancers who are at an even higher risk of bleeding and can be further burdened by the inconvenience of daily injections,” said Dan Bloomfield, Chief Medical Officer at Anthos Therapeutics. “Fast track designation by the FDA is a significant milestone for abelacimab and Anthos Therapeutics, but more importantly represents another hopeful step forward for patients. We look forward to working closely with the FDA on our clinical trial program to bring once-monthly abelacimab to patients in need.”

“Caring for cancer patients is a delicate and complex process, requiring a fine balance between the risks and benefits of their anticoagulant treatments. Managing thrombosis episodes is of the utmost importance for physicians, patients, and their caregivers, as untreated blood clots or bleeding episodes associated with currently available anticoagulants, can have dire consequences,” said Jean Marie Connors, M.D., Associate Professor of Hematology at Harvard Medical School. “The hemostasis sparing potential of FXI inhibitors, such as abelacimab, may represent an important treatment advance in how we manage patients moving forward.”
MB Bureau