Therapy Areas: Inflammatory Diseases
Bayer wins US FDA approval for Gadato to assess myocardial perfusion and late gadolinium enhancement in adult patients with CAD
16 July 2019 -

Healthcare company Bayer reported on Monday the receipt of US Food and Drug Administration (FDA) approval for Gadavist (gadobutrol) injection for use in cardiac magnetic resonance (MR) imaging to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (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. Cholesterol-containing deposits (plaque) in the arteries and inflammation are usually the cause of CAD.

The company said Gadavist is now the first and only contrast agent US FDA approved for use in cardiac MR, an important diagnostic tool for patients with CAD.

Gadavist, also known as Gadovist and Gadovist 1.0 in other regions, is the US brand name of the aqueous 1.0M solution of gadobutrol, a gadolinium (Gd)-based extracellular contrast agent for MRI with a macrocyclic structure, disclosed the company.

This US FDA approval was based on the company's two multinational, non-randomised, 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. The cardiac MR is now the fourth US FDA approved indication for Gadavist.

In addition, the Society for Cardiovascular Magnetic Resonance recognizes cardiac MR as a non-invasive tool that provides relevant and actionable information to healthcare professionals.