US FDA advisory backs Boehringer Ingelheim's Pradaxa, putting firm ahead in the race to get new blood thinner on US market

The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee yesterday voted unanimously (nine to zero) in favor of approving German independent drug major Boehringer Ingelheim’s Pradaxa (dabigatran etexilate) for stroke prevention in patients with atrial fibrillation (AFib), putting the company ahead in the race to replace the long-used anticoagulant warfarin in the world’s largest drug market.

Beyond the one key vote, the Committee was mixed on whether both the 110mg and 150mg doses should be approved and for whether the product label should include a superiority claim for Pradaxa over warfarin. There were no formal votes on these issues, however, and it will be up to the FDA to decide how it wants to incorporate all of the comments from the Committee into the final product label. The FDA Action Date is October 19, 2010.

For 50 years, warfarin has been the only oral anticoagulant available in the USA for stroke prevention in patients with AFib. Current guidelines for patients with non-valvular AFib treated with warfarin recommend maintaining an INR control range of 2.0-3.0 through regular blood monitoring and dose adjustments. The RE-LY study (see details below) on which the New Drug Application for Pradaxa is based established the safety and efficacy profile of dabigatran without INR monitoring, dose adjustments or food restrictions.