Bristol-Myers Squibb and Pfizer announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE following initial therapy.
The approval for the new indications was based on data from the global AMPLIFY and AMPLIFY-EXT studies. AMPLIFY was a randomized, double-blind trial that included patients with confirmed symptomatic DVT or PE (n=2609 [Eliquis] and n=2635 [standard of care]).
Results showed that Eliquis 10mg twice daily for one week followed by 5mg twice daily for six months showed effiacy comparable to standard of care in treating DVT/PE patients for the primary efficacy composite endpoint of recurrent, symptomatic VTE, or VTE-related death (2.3% vs. 2.7%, RR 0.84, 95% CI: 0.60-1.18; P<0.0001). Eliquis also demonstrated superiority in the primary safety endpoint of major bleeding vs. standard of care (0.6% vs. 1.8%, RR 0.31; 95% CI: 0.17-0.55; P<0.0001).
Eliquis is already approved to reduce risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF), and for prophylaxis of DVT, which may lead to pulmonary embolism in patients who have undergone hip or knee replacement surgery. Eliquis is available in 2.5mg and 5mg strength tablets.
For more information call (800) 721-5072 or visit Eliquis.com.