Reviewers back Pradaxa in briefing docs

FDA reviewers recommended approval of Pradaxa dabigatran from Boehringer Ingelheim GmbH (Ingelheim, Germany) in briefing documents posted ahead of Monday's advisory committee meeting to discuss the product to prevent stroke and systemic embolism in patients with atrial fibrillation (AF). While reviewers agreed that the 150 mg dose should be approved, one pair of reviewers said the 110 mg dose should not be approved because the higher dose provided greater net benefit. Another reviewer recommended the lower dose be used in patients at high risk of bleeding, specifically patients over 75 years of age with concomitant aspirin use or patients who are unable to tolerate the higher dose.

FDA will ask the Cardiovascular and Renal Drugs Advisory Committee to comment on the design and conduct of the Phase III RE-LY trial, including the company's choice of a non-inferiority margin of 1.46, even though FDA had recommended a margin of 1.38. However, the documents noted that Pradaxa met the trial's primary endpoint of non-inferiority to warfarin in reducing stroke and systemic embolism using both the company's and FDA's margins. ...