Gadobutrol wins major new indication FDA approved gadobutrol (Gadavist) as the first contrast agent for cardiac MRI, manufacturer Bayer announced. The gadolinium-based injection is indicated to assess myocardial perfusion and late gadolinium enhancement in adults with known or suspected coronary artery disease (CAD). Approval was based primarily on two open-label but blinded-read phase III studies in adults with CAD suspected or known from signs and symptoms: In GadaCAD 1 with 426 patients, cardiac MRI with the contrast agent had subject-based sensitivity for 50% or greater stenosis of 64.5% to 76.6% (meeting success criteria for one of the three readers) and subject-based specificity of 85.1% to 92.3%. In GadaCAD 2 with 478 patients, subject-based sensitivity was 56.0% to 64.7% for 50% or greater stenosis, which didn't meet success criteria for any of the three readers, and subject-based specificity was 85.3% to 89.5%. In secondary analyses of these trials, gadobutrol-enhancement did better at diagnosing stenoses of at least 70% and met all success criteria for both trials in that regard. Gadobutrol got its first FDA approval in 2011 for use with MRI of those age 2 and older to detect and visualize blood-brain barrier disruption or abnormal vascularity of the central nervous system. The same use in younger children was approved in 2014, along with a third indication for breast cancer imaging in adults. In 2016, gadobutrol gained an indication for use with magnetic resonance angiography of known or suspected supra-aortic or renal artery disease in adults and children. The contrast agent carries a black box warning for nephrogenic systemic fibrosis risk in patients with impaired elimination of the drugs. It can result in fatal or debilitating fibrosis of the skin, muscle, and internal organs and particularly affects those with chronic, severe kidney disease or acute kidney injury. Source
