Boehringer Ingelheim receives MA approval from European Commission for the use of Pradaxa® (dabigatran etexilate) for the treatment and prevention of venous thromboembolic events in children from birth to less than 18 years of age

Boehringer Ingelheim has received marketing authorization (MA) approval from the European Commission (EC) for the use of Pradaxa® (dabigatran etexilate) for the treatment of venous thromboembolic events (VTE) and prevention of recurrent VTE in pediatric patients from birth to less than 18 years of age. Dabigatran etexilate will be approved for this use in all European Union (EU) Member States, as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.

Three different formulations for dabigatran etexilate have been developed in its pediatric indication, each targeted to specific age groups, providing physicians with oral dosing options that are better suited to younger patients. As well as the already registered capsules, which will be available for children 8 years and older, additional dosing forms, coated granules and oral solution, will be introduced to serve the needs of younger children who are not able to swallow a capsule.

Up until this point, there has been no approved therapy for the treatment of VTE or prevention of recurrent VTE in children, and current standard of care (SOC) is associated with a range of limitations, including the need for frequent monitoring of anticoagulation level or burden of daily injections. The updated indication for dabigatran etexilate provides pediatric patients and healthcare professionals access to an oral anticoagulant therapy, for which the risk-benefit profile has been thoroughly assessed by a health authority.

The EC decision is based on a dedicated clinical pediatric program for dabigatran, including the DIVERSITY study. The data add to the established and well-documented safety and efficacy profile of dabigatran etexilate in adults, which has received regulatory approvals in over 100 countries to date. Dabigatran etexilate has helped thousands of adult patients and continues to make a positive difference to patients’ lives today.