FDA Plays It Safe With Boehringer Ingelheim's Pradaxa By Approving A Single Dosing Option
This article was originally published in The Pink Sheet Daily
Regulators accept bleeding risk for superiority over warfarin, staying away from a temptingly safer but less effective dabigatran dose.
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Bad press and lawsuits related to bleeding events for Boehringer Ingelheim’s novel anticoagulant Pradaxa create a window of opportunity for Eliquis, which is pending approval in the U.S. and could have what it takes to tip the market away from generic warfarin.
Data from the pilot program a “driving factor” in the agency’s decision against changing its recommendations for the blood thinner following reports of increased serious bleeding events.
Update of label not based on new post-NDA or post-marketing data, but on a fuller review of pivotal trial data and discussions between Boehringer Ingelheim and FDA.