FDA has approved Boehringer Ingelheim’s Pradaxa (dabigatran etexilate) oral pellets for children with venous thromboembolism who are between three months and under 12 years old.
The indication stipulates that children receiving Pradaxa have received prior treatment with an injectable blood thinner given by injection for at least five days.
FDA has also approved Pradaxa in capsule form to treat blood clots in patients eight years and older with venous thromboembolism. That approval also requires that the patients receive a prior injectable blood thinner for at least five days. FDA has also approved the use of Pradaxa to prevent recurrent clots in patients eight and older who finished treatment for their first venous thromboembolism.
Besides Pradaxa, there is no other approved oral blood thinner for children.
The drug first won FDA approval in 2010 to prevent stroke and systemic embolism in adults 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,” explained Dr. Ann Farrell, director of the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research, in a statement.
Pradaxa is one of Boehringer Ingelheim’s best-selling products.
In 2020, Pradaxa sales were €1.492 billion ($1.70 billion).
Last November, Boehringer settled 2,935 lawsuits that accused the company of failing to warn patients of potential bleeding risks associated with the drug.