Safety and efficacy established for Pradaxa in management of VTE in children

9 July 2019

Results from two pediatric studies of Pradaxa (dabigatran etexilate mesylate) have been presented at the International Society on Thrombosis and Hemostasis (ISTH) 2019 Congress in Melbourne, Australia.

The Phase IIb/III DIVERSITY study showed Boehringer Ingelheim’s Pradaxa to be as effective and to have a comparable safety profile to the current standard of care (SOC) for the treatment of acute venous thromboembolism (VTE) in children. A favorable safety profile for Pradaxa was also established in a second study, the first of its kind to assess a direct oral anticoagulant (DOAC) for the secondary prevention of VTE in children with persistent VTE risk factors.

Current SOC for treatment and prevention of VTE in children have several limitations, including the need for frequent monitoring and non-oral means of administration. The aim of these new Pradaxa studies was to provide additional insight and knowledge on anticoagulation in pediatric patients with VTE, or at risk of recurrent VTE.

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