Bayer’s Gadavist Approved by FDA for MRI in Infants

Bayer HealthCare's Gadavist (gadobutrol) injection contrast medium has been approved by the US Food and Drug Administration for use with magnetic resonance imaging (MRI) in pediatric patients less than two years of age, including newborns (term neonates), to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.

Since 2011, Gadavist has been US-approved for imaging in patient populations over the age of two. In June 2014, it was approved for MRI of the breast.

Bayer said the FDA's priority review was based on a study showing that the pharmacokinetic (PK) and safety profiles in pediatric patients under two 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 two, and there has been a significant need to better understand how they work in our youngest patients,'" said Ravi Bhargava, study investigator and pediatric radiologist at the University of Alberta in Edmonton, Canada.

According to Bayer, Gadavist is the first FDA-approved gadolinium-based contrast agent for pediatric patients under two, including term neonates. In the EU a respective supplemental application for Gadovist (trade name for Gadavist outside the US) is currently undergoing regulatory review.

The study, which enrolled 47 pediatric patients with ages spanning from term neonates to 23 months with normal renal function from nine centers across US, as well as in Canada and Europe, found that the Gadavist adverse event (AE) profile was consistent with what has been seen in older populations, Bayer said.