Bayer HealthCare’s Gadovist approved for use in infancy

Bayer HealthCare has announced that its contrast agent Gadovist has received a label extension in the EU for use among infant patients.

The gadolinium-based extracellular contrast agent has been ratified for use with magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) in paediatric patients below the age of two, including term newborns.

An international multi-centre study has demonstrated that the pharmacokinetic and safety profiles of Gadovist in these infant patients were similar to that of older children and adults at standard dose, meaning the same weight-based dosing can be used as in older patients.

The expanded use is for existing approved contrast-enhanced diagnostic imaging indications in older populations, including contrast-enhanced MRA and MRI of the central nervous system, liver, kidneys and other regions of the whole body.

Dr Christiane Pering, chief medical officer and head of innovation at Bayer HealthCare's medical care division, said: "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."

This comes after the firm received a similar approval from the US Food and Drug Administration at the start of the year.