Pfizer’s Fragmin injection secures FDA approval in paediatric symptomatic venous thromboembolism

pharmafile | May 17, 2019 | News story | Medical Communications, Sales and Marketing |  FDA, Fragmin, Pfizer, pharma 

The FDA has announced its approval of Pfizer’s anticoagulant injection Fragmin (dalteparin sodium) for subcutaneous use as a treatment to reduce the recurrence of symptomatic venous thromboembolism (VTE) in children at least one month of age.

Data submitted in support of the application was drawn from 38 paediatric participants with the condition; it was found that 21 patients achieved resolution of the qualifying VTE, while seven showed regression and two did not see their condition change. None of the participants saw their condition worsen, while on patient saw a recurrence of VTE.

VTE covers deep vein thrombosis – a blood clot in the deep veins of the leg – and pulmonary embolism – a blood clot of the lungs – both of which can be fatal. It is common for secondary complications to occur, including venous catheter, cancer, congenital heart disease, infection or trauma, and in children the condition is linked to an elevated risk of recurrence, as well as in-hospital mortality 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,” explained Dr Richard Pazdur, 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. “Prior to this approval, there had been no FDA-approved therapies to treat VTE in paediatric patients. Given the unmet need, we granted the Fragmin application priority review and today we are approving it as the first anticoagulant indicated for paediatric patients. We remain committed to advancing treatments for children with unmet medical needs.”

Matt Fellows