Panel Endorses New Blood Thinner
Tuesday, September 21, 2010
By: Emily P. Walker

MedPage Today

An FDA advisory panel has voted unanimously to recommend approval of the investigational anticoagulant dabigatran to reduce the risk of stroke and non-CNS systemic embolism in patients with atrial fibrillation.

The Cardiovascular and Renal Drugs Advisory Committee on Monday voted 9 to 0 that dabigatran works at least as well as the popular blood thinner warfarin. However, because dabigatran doesn't require laboratory monitoring, it doesn't present some of the same issues that make warfarin notoriously difficult to use.

The positive vote was no surprise: FDA reviewers last week released a glowing review of dabigatran, made by Boehringer Ingelheim, and recommended approval of the drug.

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