Bristol-Myers Squibb receives additional FDA approval for Eliquis

Bristol-Myers Squibb's Eliquis drug has been granted a Supplemental New Drug Application by the US Food and Drug Administration (FDA) and can now be used for the prophylaxis of deep vein thrombosis (DVT) in patients who have undergone surgery to replace a hip or knee joint.

Brian Daniels, senior vice-president of global development and medical affairs, said: "FDA approval of Eliquis for DVT prophylaxis in patients who have undergone hip or knee replacement is a significant milestone for this important medicine, which is also approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation."

DVT is a blood clot that develops in a large vein – traditionally in the lower leg, pelvis or thigh – and can lead to pulmonary embolism if all or part of the clot travels to the lungs, blocking one or more blood vessels, which may result in sudden death. 

The additional approval for the treatment follows three clinical trials, assessing more than 11,000 patients and demonstrating the safety and efficacy of Eliquis for this application.