FDA Permits Gadavist Injection in Younger Pediatric Patients

The FDA has approved Bayer HealthCare’s gadobutrol (Gadavist) injection for use with magnetic resonance imaging (MRI) in pediatric patients aged <2 years to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.

Gadavist was initially approved for this use in the United States in March 2011, but at that time, it was indicated exclusively for patients aged older than 2 years. The drug was further approved in June 2014 for MRI of the breast to detect potential breast disease. With the FDA’s most recent nod, Gadavist has become the first gadolinium-based contrast agent for patients aged <2 years, including term neonates.

“The approval provides guidance to physicians on how to use Gadavist in these young patients,” said Christiane Pering, chief medical officer and head of innovation within Bayer’s Medical Care division, in a press release. “With this label expansion, Gadavist is appropriate to use for MRI of the central nervous system at a standard dose of 0.1 mmol/kg for patients of all ages — term neonates to adults.”

The FDA based its approval on a study that enrolled 47 pediatric patients with ages ranging from term neonates to 23 months who had normal renal function. The results of the study demonstrated that the pharmacokinetic and safety profiles in pediatric patients <2 years of age were similar to those of older children and adults at the standard dose of 0.1 mmol/kg.

“Until this study, there were limited data regarding the use of gadolinium-based contrast agents in pediatric patients younger than 2 years of age, and there has been a significant need to better understand how they work in our youngest patients,” said study investigator and pediatric radiologist Dr. Ravi Bhargava in the press release. “Ultimately, it’s important for us to have safe and effective tools to help us accurately detect abnormalities and visualize areas of the central nervous system in children of all ages.”