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FDA Panel Votes For Dabigatran: Good News for Atrial Fibrillation Patients

Panel Unanimously Recommended that FDA Approve Dabigatran (Pradaxa) for Stroke Prevention in Afib

September 20, 2010

By Mellanie True Hills

Silver Spring, MD — An FDA panel today unanimously recommended approval of dabigatran (Pradaxa) for reducing the risk of stroke in those with atrial fibrillation (afib). The FDA doesn't have to follow the panel's recommendation, but usually does.

Gaining FDA approval appears to be just a formality because the FDA recommended that the panel approve it, and the panel did so unanimously, so FDA approval should follow quickly.

Once dabigatran receives FDA approval, it will be the first alternative to warfarin approved in the United States. While dabigatran is approved in over 70 countries for venous thromboembolisms (blood clots in the veins, often from hip or knee replacements), this may also be the first atrial fibrillation approval for dabigatran.

The FDA panel approved dabigatran on the strength of results from the Randomized Evaluation of Long-Term Anticoagulant Therapy trial, known as the RE-LY trial. Find more information about the RE-LY trial in Dabigatran Better than Warfarin for Stroke Prevention in Atrial Fibrillation.

This is great news for afib patients since dabigatran does not require the International Normalized Ratio (INR) monitoring that warfarin does, nor does it have the food and drug interactions. It is also good news in that it offers an option for atrial fibrillation patients who are not currently on warfarin due to concerns over bleeding as well as  those for whom it is difficult to monitor sufficiently, such as the elderly, or who have a difficult time staying within the normal INR "therapeutic range" of 2.0 to 3.0.

There also was no sign of liver toxicity, which is what derailed ximelagatran, a previously-promising alternative to warfarin, several years ago.

The biggest controversy of the day was whether the FDA should approve both the 110 mg and 150 mg doses, or just the higher dose. The panel, in a straw poll, was split, but slightly favored recommending both doses. Those with concerns felt that some doctors might not read up on the distinctions between doses and thus some patients might end up with suboptimal treatment.

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Last Modified September 20, 2010

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