Bayer's Gadavist (gadobutrol) injection, a gadolinium-based contrast agent, received FDA approval and can now be used with magnetic resonance angiography (MRA) to evaluate supra-aortic or renal artery disease in the U.S.

Gadavist is the first contrast agent approved by the FDA for use in MRA to evaluate known or suspected disease in the supra-aortic arteries, and the approval is based on the results of two, multi-center, Phase 3, open-label clinical studies — the Gadavist-Enhanced MRA of the Supra-Aortic Vessels (GEMSAV) study, and the Gadavist-Enhanced Renal Artery MRA (GRAMS) study.

The GEMSAV study evaluated 457 patients while the GRAMS study analyzed 292 patients, and it was discovered that Gadavist significantly improved visualization or assessability when compared to non-enhanced MRA, and was not inferior in terms of sensitivity to non-enhanced MRA.
“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," Dr. Thomas Balzer, vice president and head medical and clinical affairs of radiology at Bayer, told HCB News.

In March 2011, for adults and children in the U.S., the injection was approved for intravenous use in MR to detect and visualize with disrupted blood brain barrier or abnormal vascularity in the central nervous system.

Three years later in December 2014, the injection was approved for use in children under two years. In June 2014, Gadavist was approved for breast MR to assess malignant breast diseases.

The agent is gadolinium-based, and there have been some concerns regarding gadolinium safety since it can accumulate in the brain. However, the overall safety results from the two studies are consistent with the safety data observed in clinical trials with more than 6,000 subjects.

“To date, as noted by the FDA in its Safety Communication of July 2015, no signs or symptoms of adverse health effects nor pathologic changes have been associated with these gadolinium deposits in the brain,” said Balzer.

Currently, the company has two Phase 3 investigational studies evaluating Gadavist in cardiac MR to detect coronary artery disease in patients clinically presenting with angina or myocardial infarction, said Balzer.

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