The FDA expanded the approvals of Bayer’s Gadavist MRI contrast agent, clearing it to help gauge the blood supply of the heart muscle as well as the rates of myocardial perfusion at rest and during times of stress.
The agency also approved the gadobutrol injection for late gadolinium enhancement in adults to help predict adverse cardiovascular events related to suspected or previously known coronary artery disease, one of the most common forms of heart disease and failure.
Bayer describes Gadavist as the first contrast agent approved for use as a diagnostic tool in cardiac MRI scans. The agent was first approved in the U.S. in 2011 to help physicians visualize the vascular networks of the central nervous system and identify disruptions in the blood-brain barrier.
The FDA later expanded Gadavist’s use in 2014 to help spot breast cancer in an MRI, and in 2016 it was approved for magnetic resonance angiography scans of patients being evaluated for supra-aortic or renal artery disease. It is also known as Gadovist in other regions.
The latest approval was based on two multinational phase 3 studies of nearly 800 patients evaluated for the agent’s ability to help spot known coronary artery disease or confirm suspected cases based on their symptoms.
Gadavist, along with other gadolinium-based contrast agents, carries an FDA boxed warning for increased risks of nephrogenic systemic fibrosis, a potentially fatal skin condition that can affect patients with impaired elimination of the injection, such as those with chronic kidney disease or injuries.
And last year, the FDA required new medication guides for the class of agents—and ordered manufacturers to conduct additional human and animal safety studies—concerning other issues related to gadolinium being retained in the body for months or years, including in the brain.
The agency said that the retention has not been directly linked to adverse effects in patients with normal kidney function, and it concluded that the diagnostic benefits of approved agents continues to outweigh the potential risks.