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FDA will give BMS-Pfizer's Eliquis a priority review

US regulator the Food and Drug Administration grants Bristol-Myers Squibb and Pfizer’s oral anticoagulant an accelerated review

Pfizer and Bristol-Myers Squibb's blood thinning drug Eliquis (apixaban) has been accepted for priority review by the US Food and Drug Administration (FDA).

The oral anticoagulant will be assessed by the US regulator as a preventative treatment for stroke and systemic embolism in patients with atrial fibrillation with a decision due within the next four months.

This is two months quicker than the six months the FDA normally allows for priority review, which it grants to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.

Pfizer and BMS backed up their review application with data from the ARISTOTLE study. The phase III trial evaluated the safety and efficacy of the drug for the prevention of stroke or systemic embolism in about 24,000 patients with atrial fibrillation in comparison to standard treatment.

Results from the study have been positive, demonstrating a 21 per cent reduced risk of stroke or systemic embolism for patients taking Eliquis compared to standard treatment warfarin.

Data from a separate trial called AVERROES was also used to demonstrate Eliquis superiority to aspirin cut the risk of stroke and systemic embolism without increasing major bleeding in patients with atrial fibrillation who weren't candidates for warfarin therapy.

The FDA is aiming to complete the review process by March 28, 2012.

News that the FDA will fast-track its appraisal of the drug comes shortly after UK cost-effectiveness watchdog the National Institute for Health and Clinical Excellence (NICE) issued final draft guidance recommending Eliquis for use in the NHS for the separate indication of prevention of blood clots in patients after surgery. This too was after a fast-tracked review process.

Meanwhile, Eliquis is also currently under review for the same preventative indication by the European Medicines Agency (EMA).

30th November 2011

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