FDA Clears Gadavist Injection

Recently, FDA has approved Gadavist injection for use in Cardiac MRI to assess myocardial perfusion in adult patients. Gadavist injection is the first and only contrast agent which may be used in cardiac MRI.

Gadavist approval was based on two multinational, non-randomized, blinded-read phase 3 studies involving almost 1,000 adults with suspected/known CAD.Nearly 800 of those patients were evaluated for efficacy. 

Gadavist injection is a gadolinium-based contrast agent indicated for use with MRI:

• To detect and visualize areas with disrupted blood–brain barrier (BBB) and/or abnormal vascularity of the central nervous system in adult and pediatric patients including term neonates.
• To assess the presence and extent of malignant breast disease in adult patients.
• To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected CAD.

A disease that affects approximately 16.5 million Americans, CAD develops when the major blood vessels that supply the heart with blood, oxygen and nutrients (coronary arteries) become damaged or diseased.1,5 Cholesterol-containing deposits (plaque) in the arteries and inflammation are usually the cause of CAD. When plaque builds up, it narrows the coronary arteries, decreasing blood flow to the heart. Eventually, the decreased blood flow may cause chest pain (angina), shortness of breath, or other coronary artery disease signs and symptoms. A complete blockage can cause a heart attack.

“This latest FDA approval represents another first from Bayer, as Gadavist is the first and only contrast agent approved for cardiac MR,” said Dennis Durmis, SVP and Head of Americas Region at Bayer Radiology. “Not only does this approval add to our existing indications for Gadavist, expanding scientific knowledge, but also underscores our dedication to research and provides radiologists and cardiologists with another diagnostic option as they manage their patients with known or suspected CAD.”