Berlin, July 15, 2019?? Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Gadavist? (gadobutrol) injection for use in cardiac magnetic resonance imaging (CMRI) to assess myocardial perfusion and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). The FDA approval is based on two prospective, open-label, non-randomized, multi-center, blinded-read Phase III studies, which investigated the diagnostic results of gadobutrol-enhanced cardiac MRI for the evaluation of significant CAD. ?Gadobutrol-enhanced cardiac MR demonstrated efficacy in a large global multicenter clinical trial,? said Daniel S. Berman, MD, FACC, Chief of Cardiac Imaging and Nuclear Cardiology at the Cedars-Sinai Heart Institute and the S. Mark Taper Foundation Imaging Center, Los Angeles, USA. ?The FDA approval is a landmark for making this validated, non-invasive method available to healthcare professionals to evaluate their patients for the most common form of heart disease in the world.? Cardiac MRI is a medical imaging technology for the non-invasive assessment of the function and structure of the cardiovascular system. It is derived from and based on the same basic principles as MRI, however with optimization for use in the cardiovascular system. While the American College of Radiology and the American College of Cardiology Foundation recognize multiple modalities that are appropriate for imaging the myocardium, cardiac MRI allows healthcare professionals to get more definitive, relevant and actionable answers as it provides more comprehensive information. Coronary artery disease (CAD) is the most common type of heart disease in the United States. Up to one-half of middle-aged men and one-third of middle-aged women in the U.S. are at risk of developing CAD during their lifetime. Worldwide, CAD has caused 8.8 million deaths in 2015. 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. 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 approval of the expanded use of Gadavist? is important news for the 16.5 million people in the U.S. affected by CAD because it offers them a very powerful and non-invasive diagnostic alternative?, said Thomas Balzer, MD, PhD, Head of Medical & Clinical Affairs Radiology, Bayer. ?As an industry leader in contrast media, we are dedicated to advancing science through innovation where it truly matters for patients. Using contrast-enhanced CMRI in patients with known or suspected CAD will provide cardiologists and radiologists with important information about the function of the heart muscle to support the management of patients with this highly prevalent disease." About Gadavist? (gadobutrol) Gadobutrol was first approved for contrast enhanced (CE)-MRI of the central nervous system (CNS) in 1998 and is currently approved for several indications in >100 countries, including the European Union (EU), Australia, Canada, China, South Africa, Mexico, New Zealand, Turkey, Japan, and several Asian countries. These approved indications include CE-MRI of the CNS, CE-MRA (2003), CE-MRI of the liver and kidneys (2007), and CE-MRI of all body regions (whole body) (2012) in the EU and other countries. Gadobutrol injection was first approved in the U.S. in March 2011 for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. It was further approved in the U.S. in 2014 for MRI of the breast to assess the presence and extent of malignant breast disease and for pediatric patients less than 2 years of age, including term neonates, to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. In 2016, it was approved in the U.S. for use with magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients (including term neonates). Gadavist?, also known as Gadovist? and Gadovist?1.0 in other regions, is the U.S. brand name of the aqueous 1.0M solution of gadobutrol, a gadolinium (Gd)-based extracellular contrast agent for MRI with a macrocyclic structure. Over 50 million Gadovist / Gadavist-enhanced MRI procedures have been performed worldwide to date. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2018, the Group employed around 117,000 people and had sales of 39.6 billion euros. Capital expenditures amounted to 2.6 billion euros, R&D expenses to 5.2 billion euros. For more information, go to?www.bayer.com. Find more information at?www.pharma.bayer.com Our online press service is just a click away:?media.bayer.com Follow us on Facebook:?http://www.facebook.com/pharma.bayer Follow us on Twitter:?@BayerPharma Forward-Looking Statements? This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer?s public reports which are available on the Bayer website at?www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.