RE-LY really impresses
Boehringer's Pradaxa: Preventing stroke trumps bleeding risk for FDA panel
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.
But differences between the performance of the low dose of Pradaxa, which appeared superior to warfarin on safety, and the high dose, which appeared superior on efficacy, required panelists to choose which was more important.
In an apples-to-apples comparison made possible by the inclusion of two Pradaxa doses in the same trial, efficacy trumped safety, as the majority of panelists said reducing strokes is more important to atrial fibrillation (AF) patients than reducing bleeds.
Although there was no official vote, in a straw poll about which doses to approve, five members voted to approve both, and four voted to approve only the higher dose.
Those who voted for both doses agreed that preventing