Bayer’s Gadavist becomes first FDA-approved drug for MRI in coronary artery disease patients
pharmafile | July 16, 2019 | News story | Manufacturing and Production, Sales and Marketing | Bayer, FDA, Gadavist, coronary artery disease, pharma
The FDA has awarded approval to Bayer’s Gadavist (gadobutrol) injection, the company confirmed. The decision covers its use in cardiac magnetic resonance imaging to determine patient levels of myocardial perfusion and late gadolinium enhancement in those with known or suspected coronary artery disease (CAD), making it the first and only contrast agent approved in this indication by the US regulator, and the fourth FDA-approved indication for the drug.
CAD results from damage or disease affecting the major vessels of the heart, leading to the accumulation of cholesterol-containing plaques in the coronary arteries and the restriction of blood flow which may cause angina, shortness of breath, or even a heart attack. Around 16.5 million are affected in the US alone.
The approval decision was reached thanks to data drawn from two Phase 3 studies encompassing almost 1,000 known or suspected CAD patients.
“We now have an approved contrast agent for use in cardiac MR to assess perfusion and late gadolinium enhancement in less than one hour,” remarked Dr Scott Flamm, Head of Cardiovascular Imaging at the Cleveland Clinic. “A Gadavist-enhanced cardiac MR is a key diagnostic tool, providing additional important clinical information, which can help physicians manage their patients with known or suspected CAD.”
Dennis Durmis, SVP and Head of Americas Region at Bayer Radiology, also added: “This latest FDA approval represents another first from Bayer, as Gadavist is the first and only contrast agent approved for cardiac MR. 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.”
Matt Fellows
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