Feb. 14, 2013
/PRNewswire/ -- Guerbet, the contrast agent specialist for medical imaging, today announced that the Medical Imaging Drugs Advisory Committee to US Food and Drug Administration (FDA) has voted unanimously by votes of 17 to 0 to recommend that FDA approve the New Drug Application (NDA) for Dotarem® (gadoterate meglumine) for adults, and for pediatric use for children two years of age and older. 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.
Dotarem® is the only macrocyclic and ionic gadolinium-based contrast agent (GBCA) for the intravenous use with magnetic resonance imaging (MRI) in the brain (intracranial), spine and associated tissues in adults and pediatric patients to detect and visualize areas with disruption of the blood-brain barrier (BBB) and/or abnormal vascularity. The Guerbet NDA recommended dose is 0.1 mmol Gd/kg.
"Guerbet is very pleased with the Advisory Committee's recommendation to approve Dotarem® based on our comprehensive presentation of clinical and post-marketing data," said Yves L'Epine, CEO of Guerbet Group. "If approved by FDA, we believe Dotarem can provide another CNS imaging option for US clinicians. We are disappointed that the recommendation does not include the indication for children under two years of age, but we take the Committee's comments very seriously and will work to address all FDA questions and concerns."
The Dotarem® data presented at today's advisory committee meeting included results from two well-controlled Phase III clinical studies. These studies evaluated the diagnostic efficacy of Dotarem® in magnetic resonance imaging 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.