The approval of the drug Fragmin, an anti-coagulant subcutaneous use, will seek to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients—which can include deep vein thrombosis and pulmonary embolism that may lead to death.
VTE can develop as a secondary complication from a broad spectrum of underlying clinical conditions such as a venous catheter, cancer, infection, congenital heart disease, and trauma or surgery and is associated with an increased risk of in-hospital mortality.
Although Fragmin was approved in 1994 for adult patients, it will be the first drug for the pediatric treatment for VTE.
Learn more about 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, M.D., 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.
Some issues with Fragmin may include bleeding and hemorrhage amongst other possible complications.
“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 (blood thinner) indicated for pediatric patients. We remain committed to advancing treatments for children with unmet medical needs.”
Source: Science Daily