Bayer’s Gadavist MRI agent gets further FDA approval

Bayer’s Gadavist MRI contrast agent, described by the company as the first contrast agent approved for use as a diagnostic tool in cardiac MRI scans, has received extended FDA approval based on two multinational phase 3 studies involving almost 800 patients who were evaluated for the agent’s ability to help spot known coronary artery disease or confirm suspected cases based on their symptoms. The extended approvals are for measuring the blood supply of the heart muscle as well as the rates of myocardial perfusion at rest and during times of stress, and also for late gadolinium enhancement in adults to help predict adverse cardiovascular events related to suspected or previously known coronary artery disease.