July 15, 2019
Bayer's Gadavist Injection Contrast Agent Approved for Use in Cardiac MR in CAD Patients
July 15, 2019—Bayer announced that the FDA has approved an expanded indication for the company’s Gadavist (gadobutrol) injection for use in cardiac MR to assess myocardial perfusion and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). Cardiac MR is the fourth FDA-approved indication for Gadavist, which was first approved in 2011.
According to the company, the approval was based on two multinational, nonrandomized, blinded-read, phase 3 studies of approximately 1,000 adults with suspected or known CAD based on signs and symptoms. Approximately 800 of those patients were evaluated for efficacy.
In Bayer’s announcement, Daniel S. Berman, MD, commented, “Gadobutrol-enhanced cardiac MR demonstrated efficacy in a large, global, multicenter clinical trial. 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.” Dr. Berman is Chief of Cardiac Imaging and Nuclear Cardiology at the Cedars-Sinai Heart Institute and the S. Mark Taper Foundation Imaging Center in Los Angeles, California.
Scott Flamm, MD, added, “We now have an approved contrast agent for use in cardiac MR to assess perfusion and late gadolinium enhancement in < 1 hour. 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.” Dr. Flamm is Head of Cardiovascular Imaging at the Cleveland Clinic in Cleveland, Ohio.