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Cardio panel posits Pradaxa approval

September 21, 2010 12:47 AM UTC

An FDA panel voted 9-0 that Pradaxa dabigatran from Boehringer Ingelheim GmbH (Ingelheim, Germany) should be approved for the reduction of stroke and non-CNS systemic embolism in patients with non-valvular atrial fibrillation. The Cardiovascular and Renal Drugs Advisory Committee made its decision based on results from the Phase III RE-LY trial, which showed that each dose of Pradaxa studied (110 and 150 mg twice daily) was non-inferior to open-label, adjusted-dose warfarin on the primary endpoint of reduced stroke and systemic embolism, as well as the main safety endpoints of prespecified categories of bleeding.

The higher dose of Pradaxa also showed superiority to warfarin on the primary endpoint in RE-LY (HR:0.65; 95% C.I.: 0.52-0.81; p<0.003 for superiority). Although there was no official vote on the topic, the panel was split as to whether that claim should be on the label. Some panel members felt that only double-blind trials should contribute to superiority claims because open-label trials are susceptible to ascertainment bias. Other panelists felt that open-label trials should yield superiority claims if data are strong enough, which they said was the case in RE-LY. ...