FDA approves gadobutrol injections for use in cardiac MRIs
Bayer announced it has received approval from the FDA for its gadobutrol injection for use in cardiac MRIs to gauge myocardial perfusion and late gadolinium enhancement in adult patients with suspected CAD.
The contrast agent (Gadavist) was the first such to be approved by the FDA for use in cardiac MRI, according to a press release from the company.
“Gadobutrol-enhanced cardiac MR demonstrated efficacy in a large global multicenter clinical trial,” said Daniel S. Berman, MD, FACC, chief of cardiac imaging and nuclear cardiology at the Cedars-Sinai Heart Institute and the S. Mark Taper Foundation Imaging Center, and a member of the Cardiology Today Editorial Board, said the news release. “The FDA approval is a landmark for making this validated, noninvasive method available to health care professionals to evaluate their patients for the most common form of heart disease in the world.”
The approval of gadobutrol was based on two multinational, nonrandomized, masked-read phase 3 studies of nearly 1,000 adults with suspected or established CAD based on signs and symptoms. Of the patients included in the study, nearly 800 of the patients were evaluated for efficacy, according to the press release.
“We now have an approved contrast agent for use in cardiac MR to assess perfusion and later gadolinium enhancement in less than 1 hour,” Scott Flamm, MD, MBA, the head of cardiovascular imaging at the Cleveland Clinic, said in the release. “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.”
Disclosure: Cardiology Today could not confirm relevant financial disclosures at the time of publication.