FDA widens indication for Pradaxa

The FDA approved dabigatran for the treatment of deep vein thrombosis and pulmonary embolism in certain patients.

The anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) was approved in 2010 to reduce the risk of stroke in patients with nonvalvular atrial fibrillation. In August of 2013, the FDA agreed to review a supplemental New Drug Application for patients with deep vein thrombosis and pulmonary embolism.

The new indication includes patients who have been treated with a parenteral anticoagulant for five to 10 days, and in previously treated patients to reduce the risk of recurrent deep vein thrombosis and pulmonary embolism.

The approval was based on positive results from the RE-COVER and RE-COVER II trials, noninferiority trials that compared dabigatran with warfarin in patients with deep vein thrombosis and pulmonary embolism who were treated with parenteral anticoagulant therapy for five to 10 days. FDA reviewers also assessed results from RE-MEDY, a noninferiority trial that enrolled patients who had been previously treated for acute deep vein thrombosis and pulmonary embolism with anticoagulant therapy for three to 12 months; and RE-SONATE, a placebo-controlled trial with patients who had been previously treated for acute deep vein thrombosis and pulmonary embolism with an anticoagulant for six to 18 months.

The RE-COVER and RE-MEDY trials gave dabigatran the advantage for overall bleeding but found a higher rate of gastrointestinal bleeding with dabigatran. In RE-SONATE, dabigatran treatment substantially reduced the risk of recurrence compared with placebo but had higher rates of any bleeding, clinically relevant non-major bleeding and gastrointestinal bleeding.