The drug was initially approved by the FDA in 1994 for adults and is a type of heparin, which works as an anticoagulant. The FDA also granted this application Priority Review designation.
The efficacy of Fragmin in children was based on a single trial with 38 paediatric patients with symptomatic deep vein thrombosis and pulmonary embolism who were were treated with Fragmin for up to three months, with starting doses by age and weight.
At study completion, 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.
“Most children who have VTE are fighting a serious underlying primary illness such as cancer or congenital heart disease. Not only are they fighting a serious illness, having a condition like VTE can then lead to significant complications and even death,” said Richard Pazdur, director of the FDA’s Oncology Centre of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Centre for Drug Evaluation and Research…