The US Food and Drug Administration (FDA) has approved Bayer’s Gadavist (gadobutrol) injection for use with magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and paediatric patients (including term neonates).
The FDA approval is based on the results of two, multicentre, phase 3, 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.
“Until now, no contrast agents were FDA approved for use with MRA of the supra-aortic arteries,” said Elias Melhem, University of Maryland, and principal investigator for the GEMSAV study. “With FDA’s action, radiologists now have an approved MRA contrast agent to help visualise supra-aortic arteries in patients with known or suspected supra-aortic arterial disease, including conditions such as prior stroke or transient ischaemic attack.”
In the GEMSAV and GRAMS studies, gadobutrol met the primary objective of superior assessability and non-inferior sensitivity and specificity as compared to non-contrast MRA. Gadobutrol-enhanced MRA demonstrated statistically significant higher assessability versus non-contrast MRA images.