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 The leading web portal for pharmacy resources, news, education and careers October 22, 2017
Pharmacy Choice - Pharmaceutical News - United States : FDA approves Gadavist injection as first contrast agent in U.S. for use with magnetic resonance angiography of supra-aortic arteries [TendersInfo (India)] - October 22, 2017

Pharmacy News Article

 5/3/16 - United States : FDA approves Gadavist injection as first contrast agent in U.S. for use with magnetic resonance angiography of supra-aortic arteries [TendersInfo (India)]

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).

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.

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 Bayers 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.



(c) 2016 Euclid Infotech Pvt. Ltd. Provided by SyndiGate Media Inc. (Syndigate.info).

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