The Food and Drug Administration (FDA) has approved Fragmin (dalteparin sodium; Pfizer), a low molecular weight heparin (LMWH), for the treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in pediatric patients 1 month of age and older.
The pediatric approval of Fragmin was based on data from a single-arm, open-label clinical trial involving 38 patients with or without cancer and symptomatic deep vein thrombosis (DVT) and/or pulmonary embolism; patients were treated for up to 3 months, with starting doses calculated by age and weight. The primary endpoint of the study was the achievement of therapeutic anti-Xa levels by Day 7 of therapy during the dose adjustment period; efficacy was supported by the number of patients with lack of VTE progression or new VTE.
Results of the study showed 21 patients achieved resolution of the qualifying VTE, 7 patients showed regression, 2 patients showed no change, and no patients showed progression of the VTE; 1 patient experienced a new VTE during the study while on treatment. With regard to safety, the most common adverse reactions were injection site bruising, contusion, and epistaxis.
“Prior to this approval, there had been no FDA-approved therapies to treat VTE in pediatric patients,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Given the unmet need, we granted the Fragmin application priority review and today we are approving it as the first anticoagulant indicated for pediatric patients.”
Fragmin is also indicated in adult patients for: prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction; prophylaxis of DVT; and extended treatment of symptomatic VTE in patients with cancer.
The product is supplied in single-dose prefilled syringes (2500 IU/0.2mL, 5000 IU/0.2mL, 7500 IU/0.3mL, 12,500 IU/0.5mL, 15,000 IU/0.6mL, 18,000 IU/0.72mL), single-dose graduated syringe (10,000 IU/1mL), and multiple-dose vials (95,000 IU/3.8mL). The multiple-dose formulation should not be used in neonates and infants as it contains benzyl alcohol.
For more information visit FDA.gov.