Bristol-Myers Squibb and Pfizer have announced the US FDA's approval for Eliquis (apixaban), used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
In 2007, Pfizer and Bristol-Myers Squibb had signed a global collaboration to develop and commercialize Eliquis, an investigational oral anticoagulant discovered by Bristol-Myers Squibb.
Bristol-Myers Squibb chief executive officer Lamberto Andreotti said, "ELIQUIS is the result of leading scientific innovation and the shared vision of our alliance to introduce a new oral anticoagulant for patients with nonvalvular atrial fibrillation in the U.S."
Pfizer chairman and chief executive officer Ian Read said, "The profile of ELIQUIS, combined with the strong legacy and complementary capabilities that Pfizer and Bristol-Myers Squibb have in the cardiovascular space, positions us well to deliver this important new treatment option to patients and health care professionals."
The Eliquis clinical trial program, designed to assess risk reduction of stroke or systemic embolism in nonvalvular atrial fibrillation patients, included two phase 3 studies, ARISTOTLE and AVERROES.
ARISTOTLE assessed Eliquis' efficacy in relation to warfarin therapy in18, 201 patients with nonvalvular atrial fibrillation while AVERROES evaluated the same product against aspirin in 5,598 patients who were ineligible to be treated with warfarin.
