The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that apixaban (Eliquis) be granted marketing authorisation for the treatment of DVT (deep vein thrombosis) and PE (pulmonary embolism), and the prevention of recurrent DVT and PE, in adults.
The CHMP’s positive opinion will now be reviewed by the European Commission (EC). The decision on whether to approve apixaban for this indication will be made by the EC and will be applicable to all European Union member states plus Iceland and Norway.
The positive opinion was based on the results from the pivotal AMPLIFY and AMPLIFY-EXT studies. The AMPLIFY (Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY) study, was a randomised, double-blind, multicentre trial which evaluated apixaban therapy compared to standard of care. It included 5,395 patients (2,691 were randomised to apixaban and 2,704 were randomised to standard of care, which was initial enoxaparin treatment overlapped by warfarin therapy). Patients had confirmed symptomatic DVT or PE requiring treatment for six months. The primary efficacy endpoint was the composite endpoint of recurrent symptomatic VTE (nonfatal DVT or nonfatal PE) or VTE-related death. The primary safety endpoint was the incidence of major bleeding compared to standard of care.
The AMPLIFY-EXT (Apixaban after the initial Management of PuLmonary embolIsm and deep vein thrombosis with First-line therapY-EXTended Treatment) study was a randomised, double-blind, multicentre trial. It included 2,486 patients (842 were randomised to apixaban 2.5mg, 815 were randomised to apixaban 5mg and 829 were randomised to placebo). Patients had prior VTE and had completed six to 12 months of anticoagulation treatment for DVT or PE, and evaluated apixaban therapy compared to placebo. The primary efficacy endpoint was reduction of the composite of symptomatic, recurrent VTE and death from any cause. The primary safety endpoint was the incidence of major bleeding.
Venous thromboembolism, or VTE, is a spectrum of disease that encompasses two serious conditions: deep vein thrombosis (DVT), a blood clot in a deep vein, usually in the leg, that partially or totally blocks the flow of blood; and pulmonary embolism (PE), a blood clot in the pulmonary artery blocking one or more vessels in the lungs. VTE continues to be a major cause of morbidity and mortality, with more than one million VTE events estimated to occur annually across six major EU countries (UK, France, Germany, Italy, Spain and Sweden). Once a VTE has occurred, up to 30% of people may have a VTE recurrence in the long term, some of which could potentially be fatal.