December 16, 2014 — Data from a Bayer study in children less than 2 years of age (infants) was presented at the 2014 Radiological Society of North America (RSNA) scientific assembly and annual meeting. The primary endpoint of the study was the evaluation of the pharmacokinetics (PK) of Gadavist (gadobutrol) injection in plasma at the standard dose of 0.1 mmol/kg body weight. Safety was a secondary endpoint and the study also included a qualitative assessment of efficacy.
PK is the evaluation of the time required for a drug, once administered, to be distributed in the body and excreted, for example in the urine, and depends on patient-related factors as well as the drug's chemical properties. The data showed that the gadobutrol PK profile was similar to the PK profile in older children and adults and investigators also observed similar safety of gadobutrol in this pediatric population.
Ravi Bhargava, M.D., study investigator and pediatric radiologist, University of Alberta, Edmonton, Canada said, "Our study found that gadobutrol is distributed and eliminated from the body in children under the age of 2 in a similar way to adults and older children."
"Use of Gadavist in children less than 2 years of age to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system is currently under U.S. Food and Drug Administration (FDA) review and FDA has designated this a priority review. Currently there are no gadolinium-based contrast agents, including Gadavist, approved for use in pediatric patients younger than 2 years of age in the United States," said Christiane Pering, chief medical officer (CMO) and head of innovation, Bayer Medical Care.
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