FDA approves Gadavist for pediatric patients younger than 2

January 13, 2015

FDA has approved gadobutrol (Gadavist, Bayer HealthCare) injection for use with magnetic resonance imaging (MRI) in pediatric patients aged younger than 2 years to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. It is the first gadolinium-based contrast agent for patients aged younger than 2 years, including term neonates

FDA has approved gadobutrol (Gadavist, Bayer HealthCare) injection for use with magnetic resonance imaging (MRI) in pediatric patients aged younger than 2 years to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. It is the first gadolinium-based contrast agent for patients aged younger than 2 years, including term neonates

Gadavist was first approved for this use in the United States in March 2011 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.

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FDA’s priority review was based on a study showing that the pharmacokinetic (PK) and safety profiles in pediatric patients younger than 2 years of age were similar to that of older children and adults at standard dose (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. 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," said Ravi Bhargava, MD, study investigator and pediatric radiologist, University of Alberta, Edmonton, Canada.

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"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," said Christiane Pering, chief medical officer and head of innovation, Bayer Medical Care.