First Macrocyclic and Ionic Gadolinium-Based Contrast Medium Earns US Approval

Guerbet (Villepinte, France) reported that the US Food and Drug Administration (FDA) has approved gadoterate meglumine (Dotarem), a gadolinium-based contrast agent (GBCA) designed for intravenous (IV) use with magnetic resonance imaging (MRI) in spine, brain (intracranial), and associated tissues in pediatric and adult patients (two years of age and older) to identify and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

Dotarem, which has been commercialized widely worldwide since 1989 and more than 37 million doses administered—is the only macrocyclic and ionic GBCA. The recommended dose is 0.2 mL/kg (0.1 mmol/kg) body weight (BW). Dotarem injection 0.5 mmol/mL contains 376.9 mg/mL of gadoterate meglumine, and is available in vials and prefilled syringes.

MRI has become the cornerstone of CNS imaging since its emergence 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% of these examinations performed to image the CNS.

The Dotarem new drug application (NDA) included two phase III clinical studies. Both phase III studies evaluated the superiority of the enhanced images over the unenhanced images for CNS lesion visualization in all three coprimary 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 and safety of Dotarem-enhanced MRI.

Commercialized widely in over 70 countries in Asia, Africa Europe, Middle East, and South America, more than 37 million doses of Dotarem have been administered. The approved indications for Dotarem may vary between countries. Dotarem is the leading contrast agent in Europe with 47% market share in 2012.

Related Links:
Guerbet