French contrast developer Guerbet said the U.S. Food and Drug Administration (FDA) has approved its Dotarem gadolinium-based MRI contrast agent for use in pediatric patients younger than 2 years.
Under the supplemental indication, Dotarem (gadoterate meglumine) was approved for intravenous use with MRI in pediatric patients younger than 2 years of age, including term neonates, for detecting and visualizing areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. Guerbet said Dotarem had previously been approved for this use in patient populations older than age 2.
The FDA's review was based on a study at nine centers and involving 51 pediatric patients with normal renal function, with ages ranging from term neonates to 23 months. The study showed that the agent's pharmacokinetic and safety profiles in pediatric patients younger than 2 with a standard dose of 0.1 mmol/kg were similar to those in older children and adults, according to the company.
Dotarem has been approved by 79 countries, and more than 65 million doses have been administered worldwide, Guerbet said. No unconfounded cases of nephrogenic systemic fibrosis (NSF) have been reported, the firm said.
