Bayer HealthCare receives US approval for paediatric Gadovist indication

Bayer HealthCare has announced that its magnetic resonance imaging (MRI) contrast agent Gadovist has been approved for a paediatric indication in the US.

The US Food and Drug Administration has ratified the injectable agent for use with MRI in patients under the age of two, including term neonates, to detect and visualise areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.

Known in the US as Gadavist, the product has been shown in studies to offer pharmacokinetic and safety profiles in infants that were similar to those of older children and adults at standard dosages.

In the EU, a respective supplemental application for Gadovist is currently undergoing regulatory review.

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

This comes after the firm filed for European regulatory approval of BAY 81-8973, a new treatment for haemophilia A, last month.