The Food and Drug Administration (FDA) has approved Pradaxa (dabigatran etexilate) oral pellets for the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days, and to reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated.
The capsule formulation of Pradaxa was also approved to treat VTE in patients 8 years of age and older who have been treated with a parenteral anticoagulant for at least 5 days, and for the prevention of recurrent clots in patients 8 years of age and older who have completed treatment for their first VTE.
The approval for VTE treatment in children was supported by data from an open-label, non-inferiority, randomized phase 3 study (ClinicalTrials.gov Identifier: NCT01895777) that evaluated the efficacy and safety of Pradaxa in 267 patients less than 18 years of age with VTE. Patients were randomly assigned 2:1 to receive either Pradaxa (capsules, pellets or oral liquid formulation) or standard of care (eg, low molecular weight heparin, vitamin K antagonist or fondaparinux).
The primary efficacy measure was based on a composite endpoint of patients with complete thrombus resolution, freedom from recurrent VTE, and freedom from mortality related to VTE. Results showed that 45.8% (n=81/177) of patients treated with Pradaxa met the criteria for the composite primary endpoint compared with 42.2% (n=38/90) of patients treated with standard of care.
The safety of Pradaxa for preventing VTE recurrence in patients less than 18 years of age was evaluated in an open-label, single-arm phase 3 study (ClinicalTrials.gov Identifier: NCT02197416) in 214 patients with a history of blood clots. Findings showed that 3 patients (1.4%) had a recurrence of blood clots, which was comparable to prior standard of care treatments. During the on-treatment period, 3 patients (1.4%) experienced a major bleeding event, 3 (1.4%) had a clinically relevant non-major bleeding event, and 44 (20%) had a minor bleeding event; no deaths were reported during the study.
The most common adverse reactions observed in pediatric patients were gastrointestinal side effects (dyspepsia, upper abdominal pain, vomiting, nausea, and diarrhea) and bleeding.
Pradaxa oral pellets are supplied in child-resistant packets in 20mg, 30mg, 40mg, 50mg, 110mg, and 150mg dosage strengths.
- FDA approves first oral blood thinning medication for children. [press release]. Silver Spring, MD: US Food and Drug Administration; June 21, 2021.
- Pradaxa [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 2021.
- Pradaxa oral pellets [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 2021.