During the 54th Annual Meeting of the American Society of Hematology (ASH) now taking place in Atlanta, USA, drug majors Bristol-Myers Squibb (NYSE: BMY) and partner Pfizer (NYSE: PFE announced the results of the Phase III AMPLIFY-EXT trial, which evaluated treatment with Eliquis (apixaban) showing the drug helped prevent blood clots in the legs and lungs and kept them from recurring.
In the trial, extended treatment with Eliquis 2.5mg and 5mg twice daily, demonstrated superiority versus placebo in the reduction of the composite endpoint of symptomatic, recurrent venous thromboembolism (VTE) and death from any cause (11.6% in the placebo group, compared with 3.8% and 4.2% in the Eliquis 2.5mg and 5mg groups, respectively, P<0.001), the primary efficacy outcome of the trial.
The drug has received backing from a European Medicines Agency advisory committee but the US Food and Drug Administration has delayed its approval, most recently setting a PUDFA date of March 17, 2013 (The Pharma Letters November 2 and September 28). Should Eliquis gain clearance, it may generate sales of $4.18 billion for B-MS by 2018, according forecasts from three analysts compiled by Bloomberg.
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