FDA Approves First Anticoagulant for Pediatric Patients

The FDA approved dalteparin sodium, administered as a subcutaneous injection, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients (≥1 month).

Dalteparin sodium, a type of heparin, initially was approved in 1994 to prevent VTE in adult patients. Prior to the most recent approval, there had been no FDA-approved therapies for this indication in pediatric patients.

The FDA granted the agent priority review designation based on results of a single trial of 38 children with symptomatic deep vein thrombosis and/or pulmonary embolism. Participants received dalteparin sodium for up to three months. Twenty-one patients (55%) achieved resolution of the qualifying VTE by study completion; another seven patients showed regression, and two patients showed no change. No patients experienced progression of VTE, while one patient experienced recurrence of VTE.

The most common AEs associated with dalteparin sodium in this patient population included bleeding, thrombocytopenia, hematoma, or pain at the injection site and transient elevation of transaminases.

The agent was approved with a boxed warning alerting health-care practitioners and patients about the risks of epidural or spinal hematomas occurring in patients who are receiving low molecular weight heparins, heparinoids, or neuraxial anesthesia or who are undergoing spinal puncture. The label also directs health-care professionals to consider these risks when scheduling spinal procedures in patients who may be at a higher risk of developing VTE.

Source: FDA news release, May 16, 2019.