FDA clears Bayer’s Gadavist®️ contrast agent for use in cardiac MRI

The U.S. Food and Drug Administration (FDA) has cleared Gadavist, a gadobutrol contrast agent manufactured by Bayer, for use in cardiac magnetic resonance imaging (MRI) to assess myocardial perfusion and late gadolinium enhancement in adult patients with known or suspected coronary artery disease.

Bayer said that FDA approval was based on two multinational, non-randomized, blinded-read Phase 3 studies of almost 1,000 adults with suspected or known CAD based on signs and symptoms. Nearly 800 of those patients were evaluated for efficacy.

Cardiac MR is now the fourth FDA approved indication for Gadavist, according to Bayer. The company stated that Gadavist is the first and only contrast agent FDA approved for use in cardiac MR.