Bayer HealthCare Pharmaceuticals, Inc. announced presentation of data in a poster titled "Results from a multicenter, open-label Phase 3 study to determine the safety and efficacy of gadobutrol, a macrocyclic 1.0 molar GBCA in patients referred for contrast-enhanced MRI of the central nervous system (CNS)" at the 48th Annual Meeting of the American Society of Neuroradiology (ASNR) in Boston, MA. The results of this study of this investigational drug met all of its pre-specified primary efficacy objectives. Gadobutrol is investigational in the United States and is not approved by the U.S. Food and Drug Administration.

This phase 3 study had four primary efficacy objectives. In results comparing unenhanced CNS MRI versus the combined unenhanced and gadobutrol-enhanced CNS MRI, statistically significant superiority (P About Gadolinium Based Contrast Agents

Gadolinium based contrast agents (GBCAs) are used for the detection and visualization of certain lesions that are detected through unenhanced MRI scans. In May 2007, the FDA requested that all gadolinium-based contrast agents approved for marketing in the U.S. contain a boxed warning regarding the potential risk of Nephrogenic Systemic Fibrosis (NSF) for patients with acute or chronic severe renal insufficiency (glomerular filtration rate