Eliquis OK'd for Treating, Preventing VTE

The FDA has approved the oral anticoagulant drug apixaban (Eliquis) for treating deep vein thrombosis and pulmonary embolism and for preventing recurrent episodes of these conditions, according to the two firms selling the drug.

Previously, apixaban -- a selective Factor Xa inhibitor -- had been approved only for preventing stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

According to a statement from Bristol-Myers Squibb and Pfizer, which co-market the drug, the approval was based primarily on results from the AMPLIFY and AMPLIFY-EXT studies, which compared apixaban with enoxaparin and warfarin therapy.

In the AMPLIFY study, the risk of a composite endpoint including recurrent symptomatic venous thromboembolism (VTE) or VTE-related death was reduced 16% with apixaban versus the standard regimen.

Major bleeds were reduced by two-thirds, the companies' statement also indicated.

Safety information in the drug label notes that apixaban raises the risk of bleeding, including potentially fatal hemorrhages. The label includes boxed warnings about special risks associated with premature discontinuation of the drug and its use in patients undergoing certain spinal procedures.

Source: www.medpagetoday.com