MR Contrast Medium Receives European Approval for Use in Children

A new contrast agent has been approved for the most frequently conducted magnetic resonance imaging (MRI) examinations enhanced by contrast media. These include blood vessel imaging and examinations of the central nervous system, the liver, and the kidney. Submission for approval for the pediatric indication is currently underway in all other countries in which the agent has been approved for adults.

Bayer Schering Pharma (Berlin, Germany) successfully completed the procedure for securing approval to use the contrast medium Gadovist 1.0 in children aged seven and above in Europe's main markets. Germany will start to introduce Gadovist 1.0 for this new indication in January 2010 In addition, the Swiss Regulatory Authorities have approved Gadovist 1.0 for the use in children aged two years and older.

"When it comes to drugs, children are not simply little adults. For this reason, we incorporated a new scientific approach within the study program that helped us to substantially reduce the number of samples per child and the number of patients,” said Prof. Hans Maier, head of diagnostic imaging at Bayer Schering Pharma. "We are very pleased that we will soon be able to provide radiologists with our all-rounder Gadovist for use in children aged seven and older. We will cooperate with the authorities and will submit further data if requested with the prospect of securing approval for the use of Gadovist 1.0 in children under the age of seven in Europe's main markets.”

Gadovist is approved for the most frequently conducted magnetic resonance imaging (MRI) examinations, which are enhanced by contrast media. These include blood vessel imaging and examinations of the central nervous system, the liver, and the kidney. Submission for approval for the pediatric indication is currently underway in all other countries in which Gadovist has been approved for adults.

The open multicenter study, which was necessary for securing an indication extension for Gadovist, involved 140 children and adolescents aged two to 17 who were scheduled for a contrast-enhanced MRI scan. The study investigated the pharmacokinetics (distribution and excretion) as well as the safety and tolerability of Gadovist in young patients. It also undertook an assessment of imaging quality. It was shown that the agent is well tolerated in this patient group too. The study also demonstrated that the dosage recommendation based on body weight, which is routine in adults, could also be applied in the case of children.

Gadovist is a modern, highly efficient MRI contrast agent. It is approved for the contrast-enhanced MRI of various parts of the body, including the brain, the spinal chord, the liver, the kidney, and the blood-vessel system. With its 1.0 mol/l concentration of gadobutrol, a stable macro-cyclic gadolinium compound, Gadovist contains twice as much gadolinium per unit of volume as other extracellular contrast media available on the market.

Moreover, Gadovist has a high T1-relaxivity in plasma. Due to its combination of high concentration and high relaxivity, Gadovist exhibits the highest T1-shortening per ml of all gadolinium contrast media. This results in excellent image quality and offers practical advantages in the case of smaller injection volumes. Gadovist was approved for the first time in 1998 and is now approved in over 50 countries.

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