An FDA advisory panel yesterday unanimously recommended that the agency approve anticoagulant Pradaxa (dabigatran) to reduce the risk of stroke and blood clots in patients with atrial fibrillation. The recommendation put sponsor Boehringer Ingelheim on course to secure possible marketing clearance later this year—an FDA action date is slated for Oct. 19—giving the firm pole position in the race to bring a new kind of stroke drug to the US market and replace warfarin, a drug which has been used for decades but which requires expensive monitoring. Several other firms have blood thinners in testing for the same indication. Johnson & Johnson and Bayer expect to file rivaroxaban, sold abroad as Xarelto, later this year and are due to present data from an important trial in November at the American Heart Association meeting. Bristol-Myers Squibb and Pfizer are co-developing apixaban, while Merck and Portola plan to start a Phase III trial of betrixaban in atrial fibrillation next year. Daiichi Sankyo is also studying edoxaban.
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