FDA Approves First VTE Treatment for Pediatric Patients

The U.S. Food and Drug Administration (FDA) gave Pfizer the green light to begin marketingits treatment for symptomatic venous thromboembolism (VTE) in pediatric patients. This is the first such medicine approved for this condition in pediatric patients. On Thursday, the FDA approved Pfizer’s Fragmin (dalteparin sodium) injection for subcutaneous use to reduce the recurrence of VTE in patients one month of age or older. VTE can include a number of issues, such as deep vein thrombosis, which is a blood clot in the deep veins of the leg, as well as pulmonary embolism, a blood clot in the lungs, which can lead to death. Fragmin, an anticoagulant, was initially approved by the FDA in 1994 for use with adults. The approval for pediatric patients, which was granted under priority review, was approved following a single trial with 38 pediatric patients with symptomatic deep vein thrombosis and/or pulmonary embolism. Following the completion of the study, 21 patients achieved resolution of the qualifying VTE, seven patients showed regression, two patients showed no change, no patients experienced progression of the VTE and one patient experienced recurrence of VTE, the FDA said in its announcement.