FDA News

FDA approves Fragmin, first anticoagulant for children

The FDA today approved dalteparin sodium injection to reduce the recurrence of symptomatic venous thromboembolism among children aged at least 1 month.

Children with VTE — which includes deep vein thrombosis and pulmonary embolism and often develops as a secondary complication from an underlying condition such as cancer, infection, congenital heart disease, trauma, surgery or having a venous catheter — have an increased risk for in-hospital mortality, recurrent VTE and post-thrombotic syndrome.

“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,” 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, said in a press release. “Prior to this approval, there had been no FDA-approved therapies to treat VTE in pediatric patients. 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. We remain committed to advancing treatments for children with unmet medical needs.”

Dalteparin sodium (Fragmin, Pfizer) — a type of heparin — was first approved in 1994 for the treatment of adults.

The pediatric approval was based, in part, on data from a trial that included 38 children with symptomatic DVT or PE who received dalteparin sodium for up to 3 months at doses determined by age and weight.

Twenty-one patients achieved resolution of VTE, seven patients experienced regression and two patients had no change. None of the children experienced VTE progression; one patient experienced VTE recurrence.

Common adverse events associated with dalteparin sodium include bleeding and hemorrhage, thrombocytopenia, hematoma or pain at the injection site, and transient transaminase elevation.

Dalteparin sodium’s label includes a boxed warning to alert health care professionals and patients about the risk for epidural or spinal hematomas — which may result in long-term or permanent paralysis — among patients taking low-molecular-weight heparin or heparinoids who receive neuraxial anesthesia or undergo spinal puncture. Patients with indwelling epidural catheters; those taking NSAIDs, platelet inhibitors or other anticoagulants; those with a history of traumatic or repeated epidural or spinal punctures; and those with a history of spinal deformity or surgery are at increased risk for epidural or spinal hematomas with heparin.

Dalteparin sodium previously received priority review for this indication.

The FDA today approved dalteparin sodium injection to reduce the recurrence of symptomatic venous thromboembolism among children aged at least 1 month.

Children with VTE — which includes deep vein thrombosis and pulmonary embolism and often develops as a secondary complication from an underlying condition such as cancer, infection, congenital heart disease, trauma, surgery or having a venous catheter — have an increased risk for in-hospital mortality, recurrent VTE and post-thrombotic syndrome.

“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,” 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, said in a press release. “Prior to this approval, there had been no FDA-approved therapies to treat VTE in pediatric patients. 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. We remain committed to advancing treatments for children with unmet medical needs.”

Dalteparin sodium (Fragmin, Pfizer) — a type of heparin — was first approved in 1994 for the treatment of adults.

The pediatric approval was based, in part, on data from a trial that included 38 children with symptomatic DVT or PE who received dalteparin sodium for up to 3 months at doses determined by age and weight.

Twenty-one patients achieved resolution of VTE, seven patients experienced regression and two patients had no change. None of the children experienced VTE progression; one patient experienced VTE recurrence.

Common adverse events associated with dalteparin sodium include bleeding and hemorrhage, thrombocytopenia, hematoma or pain at the injection site, and transient transaminase elevation.

Dalteparin sodium’s label includes a boxed warning to alert health care professionals and patients about the risk for epidural or spinal hematomas — which may result in long-term or permanent paralysis — among patients taking low-molecular-weight heparin or heparinoids who receive neuraxial anesthesia or undergo spinal puncture. Patients with indwelling epidural catheters; those taking NSAIDs, platelet inhibitors or other anticoagulants; those with a history of traumatic or repeated epidural or spinal punctures; and those with a history of spinal deformity or surgery are at increased risk for epidural or spinal hematomas with heparin.

Dalteparin sodium previously received priority review for this indication.