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Jan 2, 2013

FDA Finally Approves Pfizer & BMS' Stroke Prevention Drug

  • The U.S. Food and Drug Administration (FDA) has approved Pfizer and Bristol-Myers Squibb's Eliquis® (apixaban) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In June of 2012, Pfizer and BMS failed to to win FDA approval for the drug; the agency requested additional information on data management and verification from the Phase III Aristotle trial, but didn't ask for the completion of any new studies. This annoucement comes one week after the drug was approved in Japan for the aforementioned conditions, and a little over a month after it was approved in Europe for the same.

    Eliquis is an oral Factor Xa inhibitor anticoagulant. According to the firms, by inhibiting Factor Xa, a key blood clotting protein, Eliquis can decrease thrombin generation and blood clot formation. The Eliquis clinical trial program was designed to evaluate risk reduction of stroke or systemic embolism in nonvalvular atrial fibrillation patients; it included two Phase II studies—Aristotle and Averroes—in patients with nonvalvular atrial fibrillation and at least one additional risk factor for stroke. Aristotle evaluated Eliquis versus warfarin in 18,201 patients with nonvalvular atrial fibrillation who were suitable for warfarin therapy, and Averroes evaluated Eliquis versus aspirin in 5,598 patients with nonvalvular atrial fibrillation who were considered unsuitable for treatment with warfarin. 

    According to the firms, in Aristotle, Eliquis was superior to warfarin in the primary efficacy endpoint of stroke or systemic embolism, with a 21% relative risk reduction beyond warfarin (1.27%/year versus 1.60%/year, HR=0.79, p=0.01). In Averroes, Eliquis was superior to warfarin in the key secondary endpoint of all-cause mortality, with an 11% relative risk reduction (3.5%/year versus 3.9%/year, HR=0.89, p=0.046), primarily because of a reduction in cardiovascular death, particularly stroke deaths. Nonvascular death rates were similar in the treatment arms.

    “With a population that is living longer, the prevalence of nonvalvular atrial fibrillation is increasing, but many patients are still not being managed effectively with warfarin,” said Christopher Granger, M.D., professor of medicine at Duke Clinical Research Institute, Duke University Medical Center, Durham, N.C., and Aristotle lead investigator. “Eliquis represents a significant advance over warfarin for health care professionals to reduce the risk of stroke in patients with nonvalvular atrial fibrillation.”

    Eliquis is expected to be widely available in the U.S. by the end of January 2013.


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