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FDA Extends Labeling for Magnetic Resonance Contrast Agent Gadavist (Gadobutrol)

Product now approved for children younger than 2 years of age

The FDA has approved Gadavist (gadobutrol, Bayer HealthCare) injection for use with magnetic resonance imaging (MRI) in pediatric patients younger than 2 years of age, including term neonates, to detect and visualize areas with a disrupted blood–brain barrier and/or abnormal vascularity of the central nervous system (CNS).

The FDA’s priority review was based on a study showing that the pharmacokinetic (PK) and safety profiles of gadobutrol in pediatric patients younger than 2 years of age were similar to those of older children and adults at the standard dose (0.1 mmoL/kg).

The study enrolled 47 pediatric patients with ages ranging from term neonates to 23 months with normal renal function in the U.S., Canada and Europe. Forty-four patients were evaluated for safety and efficacy, and 43 were eligible for a PK profile evaluation, including nine term neonates younger than 2 months of age.

The data showed that the PK profile of gadobutrol in pediatric patients under 2 years of age was similar to that in older pediatric patients and adults. The investigators also observed a similar safety profile for gadobutrol in this pediatric population.

Gadavist (gadobutrol) injection was first approved in the U.S. in March 2011 for intravenous use in diagnostic MRI in adults and children (2 years of age and older) to detect and visualize areas with a disrupted blood brain–barrier and/or abnormal vascularity of the CNS. Gadavist was also approved by the FDA in June 2014 for MRI of the breast to assess the presence and extent of malignant breast disease.

Gadavist consists of an aqueous 1.0-M solution of gadobutrol, a gadolinium-based extracellular contrast agent for MRI with a macrocyclic structure. The safety profile of Gadavist has been established in clinical trials involving 6,330 patients.

Source: Bayer HealthCare; January 5, 2015.

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