News | February 20, 2013

FDA Committee Recommends Approval of Guerbet’s Macrocyclic, Ionic Gadolinium MRI Contrast Agent

Dotarem Guebert LLC FDA NDA Approval Contrast Media MRI Systems

February 20, 2013 — Guerbet announced that the Medical Imaging Drugs Advisory Committee to U.S. Food and Drug Administration (FDA) has voted unanimously by votes of 17 to zero 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 six (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 U.S. 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.

Efficacy of Dotarem in the CNS indication for the pediatric population from zero to 17 years of age was assessed in pivotal study DGD-44-050 and in three open-label, single-group, non-randomized studies (DGD-3-15, DGD-3-16 and DGD-3-29).

MRI has become the mainstay of central nervous system imaging since its introduction over 20 years ago. It is estimated that there were more than 10 million contrast enhanced MRI examinations performed in the United States in 2011, with approximately 60 percent of these examinations performed to image the CNS.

The New Drug Application for gadoterate meglumine was submitted to the FDA on Sept. 20, 2012 and received priority review due to no other GBCA's being approved for children zero to two years of age. The Advisory Committee's recommendations are not binding, but FDA reviewers will consider the panel's recommendation in the final assessment of the NDA.

For more information: www.guerbet.com

Related Content

Machine Learning Uncovers New Insights Into Human Brain Through fMRI
News | Neuro Imaging | January 11, 2019
An interdisciplinary research team led by scientists from the National University of Singapore (NUS) has successfully...
Hypertension With Progressive Cerebral Small Vessel Disease Increases Cognitive Impairment Risk
News | Magnetic Resonance Imaging (MRI) | January 08, 2019
Patients with high blood pressure and progression of periventricular white matter hyperintensities showed signs of...
First Arterial and Venous Atlas of the Human Brain Released
News | Neuro Imaging | January 02, 2019
January 2, 2019 — Imagine an atlas containing an image bank of the blood vessels of the...
MRI Effective for Monitoring Liver Fat in Obese Patients
News | Magnetic Resonance Imaging (MRI) | December 28, 2018
Magnetic resonance imaging (MRI) provides a safe, noninvasive way to monitor liver fat levels in people who undergo...
FDA Approves Exablate Neuro for Tremor-Dominant Parkinson's Treatment
Technology | Focused Ultrasound Therapy | December 21, 2018
Insightec announced that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication of...
Videos | Artificial Intelligence | December 21, 2018
Enhao Gong, Ph.D., founder of Subtle Medical, an artificial intelligence (AI) company that develops products to help
Guerbet Showcases Diagnostic and Interventional Imaging Solutions at RSNA 2018
News | Interventional Radiology | December 12, 2018
Guerbet LLC USA highlighted new and next-level product offerings and partnerships in contrast media, injectors,...
Youth Football Changes Nerve Fibers in Brain

Statistically significant clusters (red-colored) showing group differences (Control vs. Football) in white matter strain along the primary (F1) and secondary (F2) fibers. While body of corpus callosum (BBC) showed relative shrinkage in Football group, the other clusters showed relative stretching of fibers. PCR: Posterior Corona Radiata, PLIC: Posterior Limb of Internal Capsule, SCR: Superior Corona Radiata, SLF: Superior Longitudinal Fasciculus, SCC: Splenium of Corpus Callosum. Image courtesy of Kim et al.

News | Neuro Imaging | December 07, 2018
Magnetic resonance imaging (MRI) scans show repetitive blows to the head result in brain changes among youth football...
Siemens Healthineers Debuts Magnetom Altea 1.5T MRI Scanner
Technology | Magnetic Resonance Imaging (MRI) | December 06, 2018
During the 104th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), Nov. 25-30...