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Bristol Myers Squibb (BMY), Pfizer (PFE) Say ELIQUIS Approved in Europe

 November 20, 2012 02:40 PM

(By Balachander) Bristol Myers Squibb Co. (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) announced approval from the European Commission for ELIQUIS for the prevention of strokes in patients with nonvalvular atrial fibrillation.

In 2007, the companies entered into a worldwide collaboration to develop and commercialize ELIQUIS, an investigational oral anticoagulant discovered by Bristol-Myers Squibb.

ELIQUIS is the only oral anticoagulant that has demonstrated superior risk reduction versus warfarin in the three important outcomes of stroke and systemic embolism, major bleeding, and all-cause mortality, the companies said.

[Related -Pfizer Inc. (PFE) Q3 Earnings Preview: What To Watch?]

"This is the first regulatory approval in any market for ELIQUIS for stroke prevention in patients with nonvalvular atrial fibrillation," Bristol Myers and Pfizer said.

In May 2011, the companies announced the first regulatory approval for ELIQUIS in the 27 countries of the European Union for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery, at a dose of 2.5 mg twice daily. 

According to the companies, ELIQUIS is an oral direct Factor Xa inhibitor, part of a new therapeutic class. By inhibiting Factor Xa, a key blood clotting protein, ELIQUIS prevents thrombin generation and blood clot formation.

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"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," commented said Pfizer CEO Ian Read.

ELIQUIS is not yet approved for the prevention of stroke or systemic embolism in patients with atrial fibrillation outside of the EU.

On Tuesday, BMY shares inched up 0.22 percent to trade at $32.08 and PFE shares added 0.27 percent to trade at $24.20.

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