Bristol‐Myers Squibb Company and Pfizer have announced that the European Commission has approved Eliquis (apixaban) for the treatment of deep vein thrombosis and pulmonary embolism, and the prevention of recurrent deep vein thrombosis and pulmonary embolism in adults. The European Commission approval applies to all European Union (EU) member states as well as Iceland and Norway. This approval broadens the clinical use for apixaban which is also approved for use in the EU for the prevention of venous thromboembolism (VTE) in adults who have undergone elective total hip or knee replacement surgery, and the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors.
“Venous thromboembolism, commonly referred to as venous thromboembolism, causes an estimated 60,000 deaths each year in the UK, based on our research. It is a major public health concern, and a burden to the UK and the NHS,” comments Alexander T Cohen, Guy’s and St Thomas’ Hospitals, London. “In fact, the total cost of the management of venous thromboembolism is estimated to be between £340 and £640 million per year, placing a significant burden on the health system. In the AMPLIFY trial apixaban was shown to be effective in the treatment of venous thromboembolism, with the additional benefit of having a significantly lower risk of bleeds compared to current standard therapies, which is positive news for patients and healthcare professionals. This improved risk benefit profile will provide clinicians with confidence when considering prescribing this treatment and provide greater reassurance for patients. The fact it is an oral treatment that does not require INR monitoring has additional advantages in terms of convenience for patients with the additional potential to reduce hospitalisations.”
The marketing authorisation follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, and is supported by two pivotal phase 3 clinical trials, AMPLIFY and AMPLIFY‐EXT.
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, non‐inferiority 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 randomised had confirmed symptomatic deep vein thrombosis or pulmonary embolism requiring treatment for six months. The primary efficacy endpoint was the composite of recurrent symptomatic venous thromboembolism (nonfatal deep vein thrombosis or nonfatal pulmonary embolism) or venous thromboembolism‐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). In this study, patients randomised had previously completed six to 12 months of anticoagulation treatment for deep vein thrombosis or pulmonary embolism and went on to receive apixaban therapy or placebo for a further 12 months. The primary efficacy endpoint was the composite of symptomatic recurrent venous thromboembolism and death from any cause. The primary safety endpoint was the incidence of major bleeding.