EU approves Gadovist for use in paediatric patients less than 2 years of age

Bayer HealthCare’s Gadovist (gadobutrol) has received a label extension in the European Union (EU) for diagnostic use with magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) in paediatric patients less than 2 years of age, including term newborns.

Country approvals by regulatory bodies across the EU will follow.

“This approval provides radiologists in Europe with an important diagnostic tool for use in the youngest paediatric population,” said Dr Gabriele Hahn, study investigator and radiologist, University of Dresden, Germany. “The study data confirm the safety profile, dose and efficacy of gadobutrol in young patients under the age of 2, including newborns.”

Safety profile of Gadovist in paediatric patients similar to that of older children and adults

The approval was based on an international multi-centre study showing that the pharmacokinetic and safety profiles of Gadovist in paediatric patients less than 2 years of age were similar to that of older children and adults at standard dose (0.1 mmol/kg), confirming that the same weight-based dosing of Gadovist can be used as in older children and adults. The expanded use is for existing approved contrast-enhanced MRI diagnostic imaging indications in older populations, for example contrast-enhanced MRA and MRI of the central nervous system (CNS), liver, kidneys and other regions of the whole body.

“To date there were only limited data regarding the use of gadolinium-based contrast agents in paediatric patients younger than 2 years of age available, and there has been a significant need to better understand how they work in the youngest of patients,” said Dr Christiane Pering, Chief Medical Officer (CMO) and Head of Innovation within Bayer HealthCare’s Medical Care division. “This study and authorisation by health authorities are important in supporting paediatric radiologists with an approved contrast agent for use in all their paediatric patients.”