FDA recommends BI's Pradaxa for approval

An FDA advisory committee has voted unanimously to approve Boehringer Ingelheim's (BI) Pradaxa for stroke prevention in patients with atrial fibrillations. The Food & Drug Administration (FDA) is expected to make a decision by October 19.

Pradaxa (dabigatran), is the most-advanced drug to reach this stage in 50 years. During this time warfarin has been the only oral anticoagulant available in the US for stroke prevention in patients with AFib. The market is estimated at more than $10bn annually.

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 established the safety and efficacy profile of dabigatran without INR monitoring, dose adjustments or food restrictions.

The FDA panel usually follows panel recommendations when deciding whether to approve new drugs. The committee voted 9 to 0.

Bayer and Johnson & Johnson have partnered on a possible rival drug. Bristol Myers Squibb and Pfizer are also developing a potential competitor.