Boehringer Ingelheim gets green light for new Pradaxa indications

The Food and Drug Administration has approved a new indication for Boehringer Ingelheim’s Pradaxa (dabigatran etexilate) oral pellets. The drug now is indicated to treat children ages 3 months to less than 12 years old with venous thromboembolism, a condition in which blood clots form in the veins, directly after they have been treated with a blood thinner given by injection for at least five days.

The FDA also approved Pradaxa oral pellets to prevent recurrent clots among patients 3 months to less than 12 years old who completed treatment for their first venous thromboembolism.

In addition, Pradaxa was approved in capsule form to treat blood clots in patients eight years and older with venous thromboembolism directly after they have been treated with a blood thinner given by injection for at least five days, and to prevent recurrent clots in patients eight years and older who completed treatment for their first venous thromboembolism.

Pradaxa is the first FDA-approved blood-thinning medication that children can take by mouth; the only other approved blood-thinning medication for children is given by injection. Pradaxa was originally approved in 2010 to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.

"The FDA is committed to helping our youngest patients with serious medical conditions have treatments that are relatively easy to take," said Ann Farrell, director of the Division of Non-Malignant Hematology in the FDA's Center for Drug Evaluation and Research. "With today's approval of Pradaxa, pediatric patients have another therapeutic option to treat and prevent potentially deadly blood clots."