US FDA accepts new drug application for Gadovist 1.0

Bayer announces that the US FDA has accepted for filing a new drug application 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 three studies.

The first phase three study compared the efficacy of combined gadobutrol-enhanced images plus unenhanced images to unenhanced images alone. The second phase three 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."

MRI is a non-invasive medical test that helps healthcare professionals diagnose medical conditions and make treatment decisions. Contrast agents are often used during an MRI to help make disease easier to see.