Bayer HealthCare Pharmaceuticals announced that the US Food and Drug Administration has approved Bayer’s gadobutrol injection Gadavist (gadobutrol), a 1.0 molar macrocyclic Gadolinium-Based Contrast Agent (GBCA) for intravenous use in diagnostic Magnetic Resonance Imaging (MRI) in adults and children age two and older to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the Central Nervous System (CNS). Gadavist is known as Gadovist outside the US and is approved in over 60 countries.
“We are very happy to offer gadobutrol injection to US healthcare providers, an important new option for contrast-enhanced MRI of the CNS,” said Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee. Our MR contrast agents are some of the most widely used today, and Bayer is proud to be a world leader in diagnostic imaging.”
MRI has been used by physicians for more than 25 years to create detailed images of the human anatomy. Contrast agents are often used to better visualize anatomic structures and pathologies.
Data submitted by Bayer for approval included results from two phase III studies that confirmed the efficacy and safety of 1.0 molar gadobutrol injection in contrast enhanced MRI of the CNS. The first phase III study compared the efficacy of combined gadobutrol-enhanced images plus un-enhanced (without injection of contrast agent) images to un-enhanced images alone.
The second phase III study used a crossover design with an active control, gadoteridol, to also compare the efficacy of the combined gadobutrol-enhanced plus un-enhanced images to unenhanced images alone, as well as to confirm non-inferiority of combined gadobutrol imaging versus combined gadoteridol imaging.
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