FDA approves Gadavist (gadobutrol), for use with magnetic resonance angiography to evaluate supra-aortic or renal artery disease- BaterHealthCare

The FDA has approved Gadavist (gadobutrol), from BayerHealthCare, for use with magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients (including term neonates).

The FDA approval is based on the results of two, multi-center, Phase III, open-label clinical studies – the GEMSAV study of patients with known, or suspected vascular disease, of the supra-aortic arteries and the GRAMS study of patients with known or suspected renal artery disease. In the GEMSAV and GRAMS studies, gadobutrol met the primary objective of superior assessability (ability to see more vessel segments) and non-inferior sensitivity and specificity as compared to non-contrast MRA. Gadobutrol-enhanced MRA demonstrated statistically significant higher assessability (visualization) versus non-contrast MRA images.

Finally, overall the safety results from the two, Phase III MRA studies in patients with known or suspected arterial disease are consistent with the safety data observed in clinical trials in more than 6,000 subjects. The results support the benefit-risk profile of Gadavist for appropriate patients. These studies are planned to be presented at medical meetings later this year.

Comment: Gadavist (gadobutrol) injection was first approved in the U.S. in March 2011 for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. Gadavist was further approved in the U.S. in June 2014 for MRI of the breast to assess the presence and extent of malignant breast disease and in December 2014 for pediatric patients less than 2 years of age, including term neonates, to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.