FDA Approves Dabigatran for VTE in Children

Late Monday, the US Food and Drug Administration approved dabigatran (Pradaxa; Boehringer Ingelheim) for treating venous thromboembolism (VTE) in children younger than 12 years old (but older than 3 months) following a minimum 5-day course with parenteral anticoagulation. The direct oral anticoagulant is now the first oral drug approved for this indication.

Dabigatran also was approved as a treatment for VTE in patients 8 years and older, directly after a course of injectable anticoagulation, to prevent recurrent clots.

Support for the approval comes in part from the DIVERSITY trial, published earlier this year in the Lancet Haematology. DIVERSITY, which enrolled 267 pediatric patients, showed that age- and weight-adjusted dabigatran was noninferior to the standard of care (low-molecular-weight heparins, unfractionated heparin, vitamin K antagonists, or fondaparinux) and demonstrated pharmacokinetic–pharmacodynamic relationships similar to those seen in adults. Additional DIVERSITY data, addressing safety and efficacy of the agent in preventing recurrent clots, were published last year in Blood.

Children most at risk of developing VTE are those with cancer, congenital heart disease, a central venous catheter, or those admitted to ICU, an FDA press release notes.