Further indications for Eliquis
pharmafile | November 22, 2012 | News story | Sales and Marketing | BMS, Eliquis, NVAF, Pfizer, Pradaxa, Xarelto
Bristol-Myers Squibb and Pfizer’s oral blood-thinner Eliquis has been approved in Europe to prevent stroke in patients with nonvalvular atrial fibrillation (NVAF).
It represents the drug’s first regulatory success in the indication for this patient group anywhere in the world, and gives it a key foothold against the competition.
Eliquis (apixaban) is an oral direct Factor Xa inhibitor, which targets a key blood-clotting protein to prevent clots forming.
Part of a field of new oral treatments, its rivals include Bayer’s Xarelto (rivaroxaban) and Boehringher Ingelheim’s Pradaxa (dabigatran), which already have this indication.
Xarelto also extended its licence in Europe this week to treat pulmonary embolism and to prevent recurrent deep vein thrombosis.
The European Commission decision means Eliquis 5mg can be used twice-daily for the prevention of stroke and systemic embolism in NVAF adults who have one or more risk factors, such as prior stroke or transient ischaemic attack.
The 50-year old drug warfarin is the current standard of care: AF sufferers are more likely to develop blood clots because their erratic heart rhythm causes turbulent blood flow within the heart.
The European Commission’s decision is based on the ARISTOTLE and AVERROES studies, which looked at patients with NVAF, comparing Eliquis to warfarin in 18,000 of them, and Eliquis to aspirin in 5,500 patients.
BMS and Pfizer say the data suggests Eliquis is the only oral anticoagulant which shows superior risk reduction versus warfarin in stroke, major bleeding and all-cause death.
“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 NVAF,” said Pfizer chief executive Ian Read.
Eliquis gained a licence last year in Europe to prevent venous thromboembolic events (VTE) in adults after hip or knee replacement surgery – again competing with Xarelto and Pradaxa.
Adam Hill
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