FDA approves Dotarem (gadoterate meglumine) for imaging in pediatric patients under two years old.- Guerbet.

The FDA has approved Dotarem (gadoterate meglumine), from Guerbet, for intravenous use with magnetic resonance imaging (MRI) in pediatric patients under two years old, including term neonates, to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system (CNS). Dotarem was previously approved for this use in patient populations over the age of two. This supplemental indication fulfills a post marketing requirement, acknowledged when Dotarem was first registered in March 2013, to strictly comply with the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c).

The FDA's review was based on a study showing that at the standard dose (0.1 mmol/kg),1 the pharmacokinetic (PK) and safety profiles in pediatric patients under two were similar to those of older children and adults. The study enrolled 51 pediatric patients in nine centers, with ages spanning from term neonates to 23 months and with normal renal function. In this pediatric population the observed safety profile of Dotarem was consistent with what has been reported in older populations. In one patient, rash was reported as a moderate adverse event. Serious AEs unrelated to Dotarem were reported in one out of 45 patients. Evaluation of images from contrast-enhanced MRI of the CNS supported extrapolation of CNS efficacy findings reported in adults and older children.