ARTICLE | Regulation

RE-LY really impresses

Boehringer's Pradaxa: Preventing stroke trumps bleeding risk for FDA panel

September 27, 2010 7:00 AM UTC

An FDA panel's review of an NDA for Pradaxa dabigatran etexilate from Boehringer Ingelheim GmbH provided a clean case study for weighing risk-benefit trade-offs of compounds to treat patients with atrial fibrillation.

Data from a single Phase III trial clearly demonstrated the compound is at least as good as warfarin, the standard of care, leading the Cardiovascular and Renal Drugs Advisory Committee to vote 9-0 that Pradaxa should be approved to reduce stroke and non-CNS systemic embolism in patients with non-valvular atrial fibrillation...