FDA Supports Pradaxa Approval, But Without Superiority Claim
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency charges the Sept. 20 Cardiovascular and Renal Drugs Advisory Committee with evaluating the relative benefit of preventing strokes with the increased risk of bleeding posed by Boehringer Ingelheim's dabigatran.
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FDA Plays It Safe With Boehringer Ingelheim's Pradaxa By Approving A Single Dosing Option
Regulators accept bleeding risk for superiority over warfarin, staying away from a temptingly safer but less effective dabigatran dose.
FDA Plays It Safe With Boehringer Ingelheim's Pradaxa By Approving A Single Dosing Option
Regulators accept bleeding risk for superiority over warfarin, staying away from a temptingly safer but less effective dabigatran dose.
FDA's Pradaxa Quandary: Clearing Both Doses Could Mask Dabigatran's Superiority
The pivotal issue remaining for FDA's review of Boehringer Ingelheim's Pradaxa (dabigatran) is whether it will clear both the 110 mg and 150 mg doses and how it can craft labeling to guide appropriate use toward the higher dose, which seems likely to gain a superiority claim over warfarin.