FDA approves Bayer’s Gadavist injection as the first magnetic resonance contrast agent for pediatric patients less than 2 years of age

The FINANCIAL — Leverkusen — Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) has approved Gadavist (gadobutrol) injection for use with magnetic resonance imaging (MRI) in pediatric patients less than 2 years of age, including term neonates, to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. Gadavist was previously approved for this use in patient populations over the age of 2. The FDA’s priority review was based on a study showing that the pharmacokinetic (PK) and safety profiles in pediatric patients less than 2 years of age were similar to that of older children and adults at standard dose (0.1 mmol/kg), according to Bayer AG.

“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 Dr. Ravi Bhargava, study investigator and pediatric radiologist, University of Alberta, Edmonton, Canada. “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,” Bhargava added.

“Gadavist is the first FDA-approved gadolinium-based contrast agent for pediatric patients under 2 years of age, including term neonates, and the approval provides guidance to physicians on how to use Gadavist in these young patients,” said Christiane Pering, Chief Medical Officer (CMO) and Head of Innovation within Bayer HealthCare’s Medical Care division. “With this label expansion, Gadavist is appropriate to use for MRI of the central nervous system at a standard dose of 0.1mmol/kg for patients of all ages – term neonates to adults,” Pering added. 

In the EU a respective supplemental application for Gadovist (trade name for Gadavist outside of the US) is currently undergoing regulatory review, according to Bayer AG.