FDA approves Gadavist for patients younger than 2

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The FDA has approved Bayer’s Gadavist (gadobutrol) injection as the first MRI contrast agent for pediatric patients younger than two years of age, including term neonates.

Specifically, the approval is for use of Gadavist to detect and visualize areas of disruption in the blood brain barrier or abnormal vascularity of the central nervous system. It had been approved for this use in 2011 in patients older than two years.

Approval was based on data from a study of 47 patients, from term neonates to 23 months of age, which demonstrated the pharmacokinetic and safety profiles of Gadavist at the standard dose of 0.1 mmol/kg in this very young population were similar to those in older patients.

“Until this study, there were limited data regarding the use of gadolinium-based contrast agents in pediatric patients younger than two years of age, and there has been a significant need to better understand how they work in our youngest patients,” Ravi Bhargava, MD, study investigator and pediatric radiologist, University of Alberta, Edmonton, Canada, said in a 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.”