BioCentury
ARTICLE | Clinical News

Pradaxa regulatory update

June 11, 2012 7:00 AM UTC

Boehringer Ingelheim said the U.S. label for Pradaxa dabigatran etexilate was updated to include data from the Phase III RE-LY trial in non-valvular atrial fibrillation (AF) patients showing that 150 mg Pradaxa was superior to warfarin in reducing stroke and systemic embolism. In 2009, Boehringer reported data from RE-LY in 18,113 patients showing that twice-daily 110 and 150 mg Pradaxa each met the primary endpoint of non-inferiority to warfarin in reducing stroke and systemic embolism. The rate of fatal bleeding for high-dose Pradaxa was 0.23% per year vs. 0.33% per year for warfarin (see BioCentury, Sept. 7, 2009). ...