Bayer's Gadavist Becomes First and Only MRI Contrast Agent Approved by FDA for Cardiac MRI in Patients with Coronary Artery Disease

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Bayer Announces on July 15 that the U.S. FDA Has Approved Gadavist Injection for Cardiac Magnetic Resonance Imaging (CMRI) to Assess Myocardial Perfusion and Late Gadolinium Enhancement (LGE) in Adult Patients with Known or Suspected Coronary Artery Disease (CAD). This approval marks a milestone, making this validated non-invasive diagnostic method available for healthcare professionals to evaluate whether patients have CAD, the most common heart disease, providing critical information on cardiac function to support the management of this highly prevalent condition.

Notably, Gadavist is the first and only magnetic resonance contrast agent approved by the FDA for cardiovascular magnetic resonance imaging (CMRI) in patients with coronary artery disease (CAD). This approval was based on two prospective, open-label, non-randomized, multicenter, blinded-reader Phase III studies that enrolled nearly 800 patients to evaluate the ability of Gadavist-enhanced CMRI to detect known CAD or to confirm suspected CAD cases based on symptoms. The results confirmed the efficacy of Gadavist.

Cardiovascular Magnetic Resonance Imaging (CMRI) is a medical imaging technique used for the non-invasive assessment of the function and structure of the cardiovascular system. Derived from Magnetic Resonance Imaging (MRI) and based on the same fundamental principles, CMRI is optimized specifically for cardiovascular applications. Although the American College of Radiology and the American Heart Foundation recognize multiple modalities suitable for cardiac imaging, CMRI provides a broader range of information, enabling healthcare professionals to obtain more definitive, relevant, and actionable answers.

Coronary artery disease (CAD) is the most common type of heart disease in the United States. In the U.S., up to half of middle-aged men and one-third of middle-aged women are at risk of developing CAD during their lifetime. Globally, CAD caused 8.8 million deaths in 2015. CAD occurs when the major blood vessels that supply the heart with blood, oxygen, and nutrients—the coronary arteries—are damaged or diseased. Cholesterol deposits (plaque) and inflammation in the arteries are usually the cause of CAD. When plaque builds up, it narrows the coronary arteries, reducing blood flow to the heart. Eventually, reduced blood flow may lead to chest pain (angina), shortness of breath, or other signs and symptoms of CAD. A complete blockage can result in a heart attack.

Gadavist is the US brand name for a 1.0 mol/L aqueous solution of gadobutrol; it is marketed as Gadovist in Europe and as Gadovist 1.0 in other regions. This gadolinium (Gd)-based extracellular contrast agent was first approved in 1998 for contrast-enhanced magnetic resonance imaging (MRI) of the central nervous system. It has since been approved for multiple indications in more than 100 countries worldwide, including in the European Union, China, Japan, and the United States.

Gadavist is the most widely used MR contrast agent in clinical practice, with over 50 million Gadavist/Gadovist-enhanced MRI examinations conducted globally to date. In China, Gadavist received approval for a new indication in April this year for use in MRI examinations of children under 2 years of age, including full-term neonates. This approval makes Gadavist the first high-concentration, high-relaxivity macrocyclic gadolinium-based contrast agent (GBCA) in China to obtain a nationwide indication for whole-body MRI in children under 2 years of age.

Currently, in the global market for magnetic resonance contrast agents, Gadavist has a concentration twice that of other gadolinium-based contrast agents (GBCAs), resulting in a smaller injection volume and facilitating more compact bolus injection. Its relaxivity, a key metric reflecting the ability to shorten T1 relaxation time, is also higher than that of most other GBCAs. Therefore, by combining high concentration with high relaxivity, Gadavist enables more comprehensive lesion detection and clearer visualization of lesion details.

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1、FDA approves Bayer's Gadavist MRI agent to help spot coronary artery disease

2、FDA approves Bayer's Gadavist™ as first and only contrast agent for use in cardiac MRI in patients with coronary artery disease