8.06.2010

FDA Accepts New Drug Application for Gadovist® 1.0 Injection in Magnetic Resonance Imaging

Berlin, August 4, 2010 – Bayer Schering Pharma AG, Berlin, Germany, announced today that the Food and Drug Administration (FDA) has accepted for filing a New Drug Application to the U.S. for gadobutrol injection, a gadolinium-based contrast agent for magnetic resonance imaging (MRI).

Gadovist® 1.0 (gadobutrol injection) is a macrocyclic, non-ionic gadolinium-based contrast agent formulated at a 1.0 molar concentration. The submission for gadobutrol injection in contrast enhanced MRI of the CNS (central nervous system) is supported by two adequate and well-controlled Phase III studies. The first Phase III study compared the efficacy of combined gadobutrol-enhanced images plus unenhanced images to unenhanced 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 unenhanced images to unenhanced images alone, as well as to confirm noninferiority of combined gadobutrol imaging versus combined gadoteridol imaging.

“If approved by the FDA, Gadovist 1.0 would complement our portfolio of contrast agents in the United States,” says Prof. Hans Maier, Head of the Diagnostic Imaging business unit at Bayer Schering Pharma in Berlin. “This submission to the FDA is an important milestone for us.”

source: Bayer