EMA Poised to Approve Expanded Dabigatran Indications

April 25, 2014

LONDON, UK — The European Medicines Agency (EMA) has set the stage for expanding the indications for the direct thrombin inhibitor dabigatran (Pradaxa, Boehringer Ingelheim). The oral anticoagulant has received a positive opinion from the agency's Committee for Medicinal Products for Human Use (CHMP) to extend its market authorization at the 110- and 150-mg twice-daily dosages to include "treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults," the agency announced today[1]. Those two dosages are already approved in Europe for prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation, with one or more risk factors, it noted.

It had already approved both the 110-mg twice-daily dosage and a 75-mg twice-daily dosage for prevention of venous thromboembolic events (VTE) in adults in the setting of elective total hip-replacement or total knee-replacement surgery.

The oral factor Xa inhibitors rivaroxaban (Xarelto, Bayer/Johnson & Johnson) and apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) are currently approved for the nonvalvular-AF and VTE-prevention indications. In addition, rivaroxaban is approved for the acute treatment of VTE, DVT, and PE.


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