Pradaxa’s U.S. Label Updated To Cite Clinical Superiority To Warfarin In Stroke Prevention
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.
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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.
Global observational study is assessing real-world experience with Pradaxa and other anticoagulants in patients with newly diagnosed atrial fibrillation and at risk of stroke. Results are due in 2020.