The novel oral anticoagulant dabigatran has been approved for treating and reducing the risk of recurrence of deep venous thrombosis and pulmonary embolism, based on the results of four phase III studies, the manufacturer announced on April 7.
Specifically, the approved indications are for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5-10 days, and to reduce the risk of recurrence of DVT and PE in patients who have been previously treated. The dose is administered twice a day.
This is the second approval for dabigatran, a direct thrombin inhibitor marketed as Pradaxa by Boehringer-Ingelheim Pharmaceuticals. It was initially approved in 2010 for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
Approval was based on four international phase III studies, according to a statement issued by the company.
The studies are the RE-COVER and RE-COVER II trials and the RE-MEDY and RE-SONATE trials.
Dabigatran is approved with a medication guide, and the prescribing information includes a boxed warning about the increased risk of thrombotic events and spinal/epidural hematoma when it is prematurely discontinued.
The updated prescribing information is available here. Serious adverse events associated with dabigatran should be reported to the Food and Drug Administration’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch.