European regulators have expanded the approved uses of Pfizer/Bristol-Myers Squibb’s bloodthinner Eliquis (apixaban), issuing a green light for the treatment of deep vein thrombosis and pulmonary embolism, and the prevention of their recurrence.
The move significantly expands the target patient population for the drug, which was previously cleared in the region for the prevention of venous thromboembolism (VTE; DVT and PE) in adults who have undergone elective total hip or knee replacement surgery, and for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors.
Approvals were based on data from two pivotal Phase III clinical trials: AMPLIFY, which showed Eliquis to be non-inferior for the treatment of recurrent VTE/VTE-related death and was statistically superior in the primary safety endpoint of major bleeding versus enoxaparin/warfarin; and AMPLIFY-EXT, a superior reduction in VTE/all-cause death with no statistical difference in major bleeding events versus placebo.
Around one million people in the EU are diagnosed with VTE every year, of which around 33% may experience a recurrence within 10 years.
