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The FDA has approved Bayer’s Gadavist injection for use with MRI in pediatric patients younger than 2.
The U.S. Food and Drug Administration (FDA) has approved the first gadolinium-based MRI contrast agent for pediatric patients younger than age 2, according to Bayer HealthCare.
Gadavist (gadobutrol) has been indicated to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system, according to Bayer, who manufactures the agent.
The approval grants expanded use to Gadavist, which was first approved in 2011 for use in patient populations older than age 2. The FDA granted the expanded use after a study showed that the pharmacokinetic (PK) and safety profiles in pediatric patients younger than age 2 were similar to that of older children and adults at a standard dose (0.1 mmol/kg), Bayer announced. Gadavist was also approved in June 2014 for MRI of the breast to assess presence and extent of malignant breast disease.
“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,” Dr. Ravi Bhargava, study investigator and pediatric radiologist, University of Alberta, Edmonton, Canada, said in a release.