EMA Approves New Dabigatran Indications

Shelley Wood

Disclosures

June 09, 2014

As expected, the European Medicines Agency (EMA) has extended the indications for the oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) to include treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults, the agency announced on Friday[1]. This follows the positive opinion on this extension from the agency's Committee for Medicinal Products for Human Use (CHMP) in April, as reported by heartwire .

The extended market authorization applies to dosages already approved in Europe, meaning physicians can immediately prescribe the drug for the new indications, a company spokesperson confirmed. The 110-mg and 150-mg twice-daily dosages are approved for prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors. A 110-mg twice-daily dosage and a 75-mg twice-daily dosage are also EMA-approved for the prevention of venous thromboembolic events (VTE) in adults in the setting of elective total hip-replacement or total knee-replacement surgery.

In the US, the FDA-approved uses of dabigatran include the stroke/systemic embolism indication in patients with nonvalvular atrial fibrillation; treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for five to 10 days; and prevention of recurrent DVT and PE in patients who have been previously treated.

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