FDA approves Bayer's Gadavist for use with MRA

The US Food and Drug Administration has approved German pharma major Bayer’s (BAYN: DE) Gadavist (gadobutrol) injection 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.1

"Until now, no contrast agents were FDA approved for use with MRA of the supra-aortic arteries," said Elias Melhem, chairman, Department of Diagnostic Radiology & Nuclear Medicine, University of Maryland, and principal investigator for the GEMSAV study. "With FDA's action, radiologists now have an approved MRA contrast agent to help visualize supra-aortic arteries in patients with known or suspected supra-aortic arterial disease, including conditions such as prior stroke or transient ischemic attack (TIA)," Dr Melhem added.