FDA approves Bayer's contrast agent Gadavist for pediatric patients

The Food and Drug Administration has approved the use of Bayer’s Gadavist® (gadobutrol) injection as a magnetic resonance contrast agent for pediatric patients under the age of two.

Gadavist is used to detect and visualize areas of with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.  The FDA had previously approved Gadavist for patients over the age of two, but conducted a priority review based on a study that showed that the pharmacokinetic (PK) and safety profiles in patients under two were similar to those over two—as well as adults—at a standard dose.

The study looked at 47 subjects ranging in age from term neonates to 23 months from nine centers in the U.S. and Canada. The study determined that the adverse event profile for Gadavist was similar in this age group to older patient populations, with one case of vomiting the only adverse event attributed to Gadavist.

"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 Ravi Bhargava, MD, study investigator and pediatric radiologist, University of Alberta, Edmonton, Canada, in a statement. "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."

The FDA has also approved Gadavist as a contrast agent for the evaluation of breast cancer.