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Eliquis receives nod in AF

Published on 24/09/12 at 11:28am
Eliquis image

Bristol-Myers Squibb and Pfizer have received a boost with the CHMP’s recommendation that their co-marketed oral anticoagulant Eliquis should gain a new licence.

The EMA’s advisory body says Eliquis (apixaban) ought to be approved for the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation (NVAF) and one or more risk factors for stroke.

This is the same indication in which two big rivals - Bayer’s Xarelto (rivaroxaban) and Boehringher Ingelheim’s Pradaxa (dabigatran) - are already slugging it out, with both already recommended by NICE.

The 50-year old drug warfarin is the current standard of care in this therapy area and Eliquis is not yet approved anywhere to combat stroke or systemic embolism in patients with AF - the most common type of irregular heart beat.

AF sufferers are more likely to develop blood clots because the erratic heart rhythm causes turbulent blood flow within the heart chambers: this is thought to be responsible for up to 20% of all ischaemic strokes and 45% of embolic ones in Europe.

The CHMP’s new opinion is based on based on the ARISTOTLE and AVERROES studies, which looked at patients with NVAF, comparing the performance of Eliquis to warfarin in 18,000 of them, and Eliquis to aspirin in 5,500 patients.

Eliquis already has a strong foothold in one key area: it gained a licence last year in Europe to prevent venous thromboembolic events (VTE) in adults after hip or knee replacement surgery, and is currently being investigated in Phase III trials for the treatment of VTE.

Here it also competes with Xarelto and Pradaxa, with all three brands looking to take the biggest share of the new oral anticoagulant market.

Pfizer and BMS agreed a deal in 2007 to develop and commercialize Eliquis, which was discovered by the latter.

Adam Hill

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