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Fourth approval for use in assessing myocardial perfusion and late gadolinium enhancement.
The FDA has approved Gadavist (gadobutrol, Bayer) as the first, and currently only, contrast agent to be used with MRI assessments of myocardial perfusion and late gadolinium enhancement in adult patients with known or suspected coronary artery disease.
"We now have an approved contrast agent for use in cardiac MR to assess perfusion and late gadolinium enhancement in less than one hour," said Scott Flamm, MD, MBA, head of Cardiovascular Imaging, Cleveland Clinic. "A Gadavist-enhanced cardiac MR is a key diagnostic tool, providing additional important clinical information, which can help physicians manage their patients with known or suspected CAD."
Approval for this indication expansion was based on two multinational nonrandomized, blinded-read Phase III studies comprising nearly 1,000 adults with suspected or known CAD. Nearly 800 of those patients were evaluated for efficacy.
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"Gadobutrol-enhanced cardiac MR demonstrated efficacy in a large global multicenter clinical trial," says Daniel S. Berman, MD, chief of Cardiac Imaging and Nuclear Cardiology at the Cedars-Sinai Heart Institute and the S. Mark Taper Foundation Imaging Center, in a statement. "The FDA approval is a landmark for making this validated, noninvasive method available to healthcare professionals to evaluate their patients for the most common form of heart disease in the world."
This is the fourth indication expansion for Gadavist. The drug was originally approved in 2011 to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients. Gadavist is also approved to assess the presence and extent of malignant breast disease (2014) and to evaluate known or suspected supra0arotic or renal artery diseases in adult and pediatric patients (including term neonates) (2016).
Gadavist is contraindicated for patients with a history of severe hypersensitivity reaction to gadobutrol, and comes with warnings including nephrogenic systemic fibrosis, anaphylactic and other hypersensitivity reactions (cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death).
Once administered, Gadolinium is retained for months or years in brain, bone, and other organs.
The most common adverse reactions reported include headache, nausea, and dizziness.