The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorisation of Bristol-Myers Squibb and Pfizer’s Eliquis (apixaban) for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as prevention of recurrent DVT and PE in adults.
The European Commission (EC) will now review CHMP’s positive opinion and will take a decision on whether to approve Eliquis, an oral selective Factor Xa inhibitor, for this indication.
Following the EC decision, the drug will be applicable to all EU member states, as well as to Iceland and Norway.
CHMP adopted positive opinion for Eliquis based on results from the pivotal AMPLIFY and AMPLIFY-EXT studies.
AMPLIFY (‘Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY’) is a randomised, double-blind, multicentre trial that included 5,395 patients with confirmed symptomatic DVT or PE requiring treatment for six months.
Of the 5,395 patients in the study, 2,691 patients were randomised to Eliquis and 2,704 were randomised to standard of care, which was initial enoxaparin treatment overlapped by warfarin therapy.
AMPLIFY study’s primary safety endpoint was the incidence of major bleeding compared with standard of care, while the primary efficacy endpoint was the composite endpoint of recurrent symptomatic VTE (nonfatal DVT or nonfatal PE) or VTE-related death.
AMPLIFY-EXT (‘Apixaban after the initial Management of PuLmonary embolIsm and deep vein thrombosis with First-line therapY-EXTended Treatment’) is a randomised, double-blind, multicentre trial that included 2,486 patients with prior VTE who had completed six to 12 months of anticoagulation treatment for DVT or PE.
Of the 2,486 patients in the study, 842 patients were randomised to Eliquis 2.5mg, 815 were randomised to Eliquis 5mg and 829 were randomised to placebo.
The study’s primary safety endpoint was the incidence of major bleeding, while the primary efficacy endpoint was reduction of the composite of symptomatic, recurrent VTE and death from any cause.
Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration in 2007 to develop and commercialise apixaban, discovered by Bristol-Myers Squibb.
Image: A Bristol-Myers Squibb R&D facility in New Jersey, the US. Photo: courtesy of Coolcaesar.