Eliquis® (apixaban) has received marketing authorisation for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and PE, in adults.(1)
The development was announced by Bristol-Myers Squibb Company and Pfizer Ltd following the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopting a positive opinion about the drug.
Eliquis® (apixaban) has received marketing authorisation for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and PE, in adults.(1)
The development was announced by Bristol-Myers Squibb Company and Pfizer Ltd following the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopting a positive opinion about the drug.
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 Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY (AMPLIFY) study, was a randomised, double-blind, multicentre trial that evaluated apixaban therapy compared with standard of care.(3) 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).(2) Patients had confirmed symptomatic DVT or PE requiring treatment for 6 months.(2) The primary efficacy endpoint was the composite endpoint of recurrent symptomatic Venous thromboembolism (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.(2)
The Apixaban after the initial Management of PuLmonary embolIsm and deep vein thrombosis with First-line therapY-EXTended Treatment (AMPLIFY-EXT) study was a randomised, double-blind, multicentre trial.(3) It included 2,486 patients (842 were randomised to apixaban 2.5 mg, 815 were randomised to apixaban 5 mg and 829 were randomised to placebo).(3) Patients had prior VTE and had completed 6 to 12 months of anticoagulation treatment for DVT or PE, and evaluated apixaban therapy compared with placebo.(3) The primary efficacy endpoint was reduction of the composite of symptomatic, recurrent VTE and death from any cause.(3) The primary safety endpoint was the incidence of major bleeding.(3)
For full Summary of Product Characteristics, please visit: http://www.medicines.org.uk/emc/medicine/24988/SPC/Eliquis+2.5+mg+film-coated+tablets/
https://www.medicines.org.uk/emc/medicine/27220/SPC/Eliquis+5+mg+film-coated+tablets/
References
- Opinion of the Committee for Medicinal Products for Human Use on a type II variation to the terms of the marketing authorisation for Eliquis (apixaban) – EMA/360384/2014 – 26 June 2014.
- Agnelli G, et al. Oral Apixaban for the Treatment of Acute Venous Thromboembolism. N Engl J Med. 2013;369:799–808.
- Agnelli G, et al. Apixaban for Extended Treatment of Venous Thromboembolism. N Engl J Med. 2013;368:699–708.
