FDA approves Pradaxa as first oral blood thinning agent for children
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The FDA approved dabigatran etexilate for multiple pediatric indications.
The agency approved dabigatran etexilate (Pradaxa, Boehringer Ingelheim) oral pellets for children aged 3 months to 11 years with venous thromboembolism who already received a blood thinner by injection for at least 5 days, as well as to prevent clots among children in the same age range who completed treatment for their first VTE.
Dabigatran etexilate oral pellets are the first FDA-approved blood thinning medication that children can take by mouth.
“The FDA is committed to helping our youngest patients with serious medical conditions have treatments that are relatively easy to take,” Ann Farrell, MD, director of the division of non-malignant hematology in the FDA’s Center for Drug Evaluation and Research, said in an agency-issued press release. “With today’s approval of Pradaxa, pediatric patients have another therapeutic option to treat and prevent potentially deadly blood clots.”
The FDA also approved Pradaxa in capsule form to treat blood clots among patients 8 years or older with VTE who already received a blood thinner by injection for at least 5 days, and to prevent recurrent clots among children in the same age range who completed treatment for their first VTE.
The agency based the approvals on results of a randomized, open-label study that included 267 children randomly assigned to dabigatran etexilate (n = 177) or standard of care (n = 90). Researchers established a composite endpoint that consisted of three clinical endpoints: no death due to blood clot, complete resolution of the blood clot, and no additional blood clots.
Eighty-one (45.8%) children assigned dabigatran etexilate and 38 (42.2%) children assigned standard of care achieved the composite endpoint.
Researchers assessed safety of the therapy in an open-label, single-arm study of 214 patients with a history of blood clots. Three patients (1.4%) experienced recurrent clots, a rate similar to that observed with prior standard-of-care therapies.
The most common adverse events among dabigatran etexilate-treated patients include digestive system symptoms and bleeding.
The FDA approved Pradaxa in 2010 to reduce risk for stroke and systemic embolism among adults with non-valvular atrial fibrillation.
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