Ingelheim, Germany:
- No approved therapy for the treatment and prevention of venous thromboembolic events in children until now
- Current standard of care often associated with frequent monitoring of anticoagulation or daily injections1
- Positive opinion is based on a dedicated clinical pediatric program for dabigatran, including the DIVERSITY study,2 which supplements dabigatran’s established and well-documented safety and efficacy profile in adults3
Boehringer Ingelheim today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the proposed indication for 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.
If the proposed indication is approved by the European Commission (EC), pediatric patients and healthcare professionals will have access to an oral anticoagulant therapy for which the risk-benefit profile has been thoroughly assessed by a health authority. At present, there is no approved therapy for the treatment or prevention of blood clots in veins (VTE) for 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.1
“It is important that healthcare professionals have access to an oral anticoagulant treatment that has gone through rigorous testing, and is as convenient as possible for children,” said Leonardo R. Brandão, Thrombosis Program Director, Associate Professor, The Hospital for Sick Children, Department of Pediatrics, University of Toronto, Toronto, Canada. “If adopted by the EC, this positive opinion could potentially lead to the availability of a treatment option that can be administered orally, does not require routine laboratory monitoring or dose titration, and is available in formulations targeted to specific age groups, including younger patients.”
“Dabigatran has a proven positive safety profile in adults, demonstrated across clinical and real-world studies,3 and we are delighted that it has now been confirmed in pediatric patients too,” said Waheed Jamal, Corporate Vice President, Head of CardioMetabolism Respiratory Medicine, Boehringer Ingelheim. “This positive opinion provides further evidence that dabigatran is suitable for use across a wide range of patient populations, with clinical experience that equates to over 10 million patient-years across all licensed indications to date. If approved, it will bring a new therapy where there are currently no licensed treatment options available.”
The positive CHMP opinion is based on a dedicated pediatric clinical program. The DIVERSITY trial demonstrated that dabigatran was non-inferior to SOC for pediatric patients at high risk of VTE, with comparable bleeding rates,2 while the Brandão L et al. study showed favorable safety results with dabigatran in children with VTE and persistent thrombosis risk factors.1
The expected approval represents an important milestone for dabigatran, building on the outcomes of its associated trials and potentially widening its patient population.
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