The drug Eliquis (apixaban) is a new anticoagulant option that is at least as effective as other current blood thinners and possibly better at reducing rates of major bleeding, according to a recent trial.
Eliquis, an oral direct Factor Xa inhibitor developed by Bristol-Myers Squibb (NYSE: BMY) and Pfizer Inc. (NYSE: PFE), was recently used in a six-month AMPLIFY trial. By inhibiting a key protein that clots blood, Eliquis prevents thrombin and blood clot formation.
Acute venous thromboembolism (VTE) is a blood clot that forms within a vein, usually in the leg. Patients with deep vein thrombosis (DVT), a type of VTE, can develop a pulmonary embolism (PE) that can become life-threatening when a blood clot blocks one or more vessels in the lungs. Each year in the US, nearly 900,000 patients are diagnosed with VTE.
AMPLIFY (Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY) was a randomized, double-blind, multi-center trial that included 5,395 patients with VTE. About one-third of those patients had a PE at the beginning of the study, which was recently published online in the New England Journal of Medicine.
Eliquis was assessed in the trial as a single agent and was compared to current standard of care, which consisted of an initial parenteral enoxaparin treatment overlapped by warfarin therapy.
Results from the study showed that Eliquis achieved similar effectiveness in the reduction of recurrent symptomatic VTE or VTE-related death compared with the current treatment. What’s more, Eliquis achieved the primary safety endpoint of superiority for major bleeding, which only occurred in 0.6% of patients given Eliquis; 1.8% of those given current standard of care experienced major bleeding.
Dr. Giancarlo Agnelli, professor of internal medicine at the University of Perugia, Italy, and lead investigator of the study, noted that the results of this trial complement results from a previously published AMPLIFY-EXT study: “Together these studies represent exciting data in the field of VTE treatment and indicate that apixaban may offer an important potential alternative in both acute and extended anticoagulation therapy for VTE patients.”
In the US, Eliquis is currently approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. While it is approved for prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery in the EU, it is not currently approved for this indication in the US.
After the successful results of the two AMPLIFY trials, Bristol-Myers Squibb and Pfizer plan to initiate regulatory filings for both initial and long-term treatment of VTE. In addition, the two companies plan to file for extended prevention of recurrent VTE. Their collaboration began in 2007 when they entered into a partnership to develop and commercialize Eliquis, which was first discovered by Bristol-Myers Squibb.