The U.S. Food and Drug Administration has announced multiple new approvals for dabigatran etexilate—and it made a little bit of history along the way.
Dabigatran etexilate, sold by Boehringer Ingelheim under the name Pradaxa, is now approved as a treatment option for venous thromboembolism in patients between the ages of three months and 12 years old. It should be taken, in the form of an oral pellet, after the patient has already been treated with a blood thinner by injection for at least five days.
The medication was also approved for the prevention of recurrent blood clots among patients from that same age group who have completed treatment for their first venous thromboembolism. Again, it is to be taken in the form of an oral pellet.
In addition, among patients eight years and older, the capsule version of dabigatran etexilate was approved for the same purposes.
This is the first time the agency has given the greenlight to a blood thinning medication that pediatric patients can take by mouth. All other medications approved for that purpose have been given by injection.
“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 a statement. “With today’s approval of Pradaxa, pediatric patients have another therapeutic option to treat and prevent potentially deadly blood clots.”
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.