FDA committee recommends approval of Dotarem (Guerbet SA) as MRI contrast agent

The Medical Imaging Drugs Advisory Committee to the FDA has voted unanimously to recommend approval of the New Drug Application (NDA) for Dotarem (gadoterate meglumine), from Guerbet SA, for adults, and for pediatric use for children two years of age and older in MRI Imaging. The Committee voted 10 to 6 (with one member abstaining) not to recommend at this time approval of the indication for children under two years of age.

The NDA is based on results from two Phase III clinical studies which evaluated the diagnostic efficacy of Dotarem in MRI scans of diseases of the central nervous system, such as primary or secondary tumors of the brain or spinal cord, inflammatory diseases such as multiple sclerosis and vascular brain diseases. Both studies evaluated the superiority of the enhanced images over the unenhanced images for central nervous system (CNS) lesion visualization in all three co-primary endpoints. All defined primary and key secondary efficacy analyses were met and support the efficacy of Dotarem at a standard dose of 0.1 mmol/kg BW. In addition to these two studies, 21 supportive clinical studies evaluated the efficacy of Dotarem-enhanced MRI.