Pfizer and Bristol-Myers Squibb will be celebrating news that their blood thinner Eliquis has been cleared in Europe to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF).
According to the firms, Eliquis (apixaban) is the only oral anticoagulant that has shown a superior risk reduction compared to veteran drug warfarin across outcomes for stroke and systemic embolism, major bleeding and all-cause mortality, and analysts believe it could become a best-in-class drug.
The decision by the European Commission - which gives the pill its first regulatory approval in any market for the indication - is based on a huge well of data from the Aristotle and Averroes Phase III clinical trials, which included around 24,000 patients.
In Aristotle, Eliquis was superior to warfarin in the primary efficacy endpoint of stroke/systemic embolism, with a 21% relative risk reduction beyond warfarin and, crucially, was also linked with a 31% lower risk for major bleeding.
“We are confident in Eliquis and its differentiated profile and believe it has the potential to transform the standard of care in stroke prevention in nonvalvular atrial fibrillation,” said Ian Read, Pfizer's chairman and chief executive.
Patients with AF have a five times greater risk of suffering a stroke, "and there remains a critical public health need for improved treatment options to reduce this risk,” said Lars Wallentin, Director and Professor of Cardiology, Uppsala Clinical Research Centre and University Hospital, Sweden, welcoming the drug's approval.
Eliquis' path to market in the US suffered did suffer a setback this year, after regulators issued a complete response letter requesting additional information on data management and verification from the Aristotle study, though no new trials were required. The companies are expecting a decision from the US Food and Drug Administration by St Patrick's Day (March 17).
In May last year, Eliquis was approved in Europe for the prevention of venous thromboembolic events (VTE) in adults who have undergone elective hip or knee replacement surgery.