The Food and Drug Administration has approved gadobutrol (Gadavist) injections, for use in conjunction with magnetic resonance angiography (MRA), to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients.
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Approval was based on a pair of open-label, phase 3 studies in which the efficacy of gadobutrol was assessed, based on visualization and performance for distinguishing between normal and abnormal anatomy. MRA with gadobutrol improved visualization by 88%-98%, compared with unenhanced MRA, in which visualization was improved by 24%-82%. Sensitivity and specificity were noninferior to unenhanced MRA.
Gadobutrol was previously indicated for use in diagnostic MRI in both adults and children to detect areas with disrupted blood-brain barrier and/or abnormal vascularity of the central nervous system, and for MRI of the breast to assess the presence and extent of malignant breast disease. The safety profile in the two current trials matched data previously gathered, with the most common adverse events including headache, nausea, and dizziness.
“Until now, no contrast agents were FDA approved for use with MRA of the supra-aortic arteries. 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,” Elias Melhem, MD, chair of the department of diagnostic radiology and nuclear medicine at the University of Maryland, Baltimore, said in the press release.
Find the full release on the Bayer website.