FDA approves Pfizer's Fragmin as first anticoagulant for children with symptomatic venous thromboembolism

The FDA on Thursday announced the authorisation of Pfizer's injectable therapy Fragmin (dalteparin) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in children aged one month and over. Richard Pazdur, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research remarked "we granted the Fragmin application priority review and today we are approving it as the first anticoagulant indicated for paediatric patients."

The FDA noted that the efficacy of Fragmin in children was based on a single 38-patient study, with study results showing that 21 patients achieved resolution of VTE, while regression of symptoms was observed in seven patients.

Fragmin, was initially approved by the FDA in 1994 for use in adults. The treatment was subsequently cleared in the US in 2007 for reducing the recurrence of VTE in patients with cancer.

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