FDA approves Gadavist® for MRA to evaluate known or suspected supra-aortic or renal artery disease
Berlin, May 2, 2016 - Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Gadavist® (gadobutrol) injection 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).(1)
The FDA approval is based on the results of two, multi-center, Phase 3, open-label clinical studies - the GEMSAV study of patients with known, or suspected vascular disease, of the supra-aortic arteries and the GRAMS study of patients with known or suspected renal artery disease.(1)

"Until now, no contrast agents were FDA approved for use with MRA of the supra-aortic arteries," said Dr. Elias Melhem, M.D., Chair, Department of Diagnostic Radiology & Nuclear Medicine, University of Maryland, and principal investigator for the GEMSAV study. "With FDA's action, radiologists in the U.S. now have an approved MRA contrast agent to help visualize supra-aortic arteries in patients with known or suspected supra-aortic arterial disease, including conditions such as prior stroke or transient ischemic attack (TIA)."

In the GEMSAV and GRAMS studies, gadobutrol met the primary objective of superior assessability (ability to see more vessel segments) and non-inferior sensitivity and specificity as compared to non-contrast MRA. Gadobutrol-enhanced MRA demonstrated statistically significant higher assessability (visualization) versus non-contrast MRA images.

"As the global market leader in contrast media for MRI, this is the third expansion of the Gadavist label in the U.S. in the past 24 months based on a robust clinical development program," said Christiane Pering, Head of R&D for Bayer Radiology. "The GEMSAV and GRAMS studies demonstrate Bayer's commitment to the diagnosis of artery disease. In particular, the GEMSAV study demonstrates the clinical value of Gadovist in supra-aortic MRA - an important tool in the diagnosis of stroke risk."

About the Studies
The GEMSAV (Gadavist-Enhanced MRA of the Supra-Aortic Vessels) study evaluated 457 patients with known or suspected disease of the supra-aortic arteries. Efficacy was evaluated based on visualization and performance for distinguishing between normal and abnormal anatomy. Significant stenosis was defined as at least 70%.

Key findings of this open-label Phase 3 study, in which Gadavist was delivered at 1.5mL/second, include:
• Gadavist MRA significantly improved visualization, or assessability, (range across three readers: 88-97%) as compared to unenhanced MRA (range across three readers: 24-82%).
• Gadavist MRA specificity for exclusion of clinically significant disease (range across three readers: 92-97%) showed non-inferiority as compared to unenhanced MRA (range across three readers: 62-89%).
• Gadavist MRA sensitivity (range across three readers: 58-60%) showed non-inferiority as compared to unenhanced MRA (range across three readers: 54-55%).
o Low sensitivity for significant arterial stenosis. For all three supra-aortic artery readers, the lower bound of confidence for the sensitivity of Gadavist MRA for detecting arterial segments with significant stenosis did not exceed 54%. A negative MRA alone should not rule out significant stenosis.(1)

The GRAMS (Gadavist-Enhanced Renal Artery MRA) study evaluated 292 patients with known or suspected disease of the renal arteries. Efficacy was evaluated based on visualization and performance for distinguishing between normal and abnormal anatomy. Significant stenosis was defined as at least 50%.(1)

Key findings of this open-label Phase 3 study, in which Gadavist was delivered at 1.5mL/second, include:
• Gadavist MRA significantly improved visualization, or assessability, (range across three readers: 96-98%) as compared to unenhanced MRA (range across three readers: 72-82 %).
• Gadavist MRA specificity for exclusion of clinically significant disease (range across three readers: 94-95%) showed non-inferiority as compared to unenhanced MRA (range across three readers: 81-85%).
• Gadavist MRA sensitivity (range across three readers: 52-54%) showed non-inferiority as compared to unenhanced MRA (range across three readers: 39-51%).
o Low sensitivity for significant arterial stenosis. For all three renal artery readers, the lower bound of confidence for the sensitivity of Gadavist MRA for detecting arterial segments with significant stenosis did not exceed 46%. A negative MRA alone should not rule out significant stenosis.(1)
• Gadavist MRA improved visualization of accessory renal arteries for surgical planning and renal donor evaluation as compared to unenhanced MRA.(1)

Finally, overall the safety results from the two, Phase 3 MRA studies in patients with known or suspected arterial disease are consistent with the safety data observed in clinical trials in more than 6,000 subjects. The results support the benefit-risk profile of Gadavist for appropriate patients.

These studies are planned to be presented at medical meetings later this spring.

About Gadavist
Gadovist (gadobutrol) was first approved in Switzerland in 1998. In 2000, it was approved in the European Union (Germany) for contrast enhancement in cranial and spinal magnetic resonance imaging (MRI) and in 2003 the indication was extended to include contrast-enhanced MRA. In 2006, Gadovist was approved for patients with high suspicion or evidence of having benign or malignant focal lesions in the liver or kidneys. Gadovist was further approved for MRI in the EU of pathologies of the whole body in 2012. The expanded use of Gadovist in pediatric populations under 2 years of age, including term neonates, was first approved in the U.S. in December 2014.

Gadovist, also known as Gadavist® in the U.S. and Gadovist® 1.0 in other regions, is the brand name of the aqueous 1.0M solution of gadobutrol, a gadolinium (Gd)-based extracellular contrast agent for MRI with a macrocyclic structure. The safety profile of Gadovist has been established in clinical trials involving more than 6,800 patients. Gadovist has been used since its first launch in more than 29 million applications and is currently the most often used MR contrast agent globally.

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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.


References
(1) Gadavist® (gadobutrol) Prescribing Information. Whippany, New Jersey, USA: Bayer Pharmaceuticals, Inc.

Bayer AG issued this content on 02 May 2016 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 02 May 2016 07:08:02 UTC. Original document available at http://www.press.bayer.com/baynews/baynews.nsf/ID/74DE26FAA849CA67C1257FA7001C6B6F?OpenDocument