Boehringer Ingelheim's Pradaxa garners FDA approval

The FDA announced Tuesday that it approved Boehringer Ingelheim's Pradaxa (dabigatran etexilate) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The oral direct thrombin inhibitor is the first new oral anticoagulant approved in the US in more than 50 years, the drugmaker reported.

The safety and efficacy of Pradaxa were studied in the RE-LY clinical trial, which compared Pradaxa with warfarin. In the trial, patients taking Pradaxa had fewer strokes than those who took warfarin. The agency's director of the division of cardiovascular and renal products for the FDA’s Center for Drug Evaluation and Research, Norman Stockbridge, noted that “unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa."

Pradaxa sets “an extremely high bar” for competitors, said Leerink Swann & Co analyst Seamus Fernandez. Rival drugs being developed include Bayer and Johnson & Johnson's Xarelto (rivaroxaban), and Pfizer and Bristol-Myers Squibb's apixaban.

Boehringer Ingelheim's anticoagulant was approved in the EU in 2008, and is approved in over 40 countries for the prevention of venous thromboembolism following hip or knee surgery.

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