FDA Approves Guerbet's Elucirem™ (Gadopiclenol) Contrast Agent
The U.S. Food and Drug Administration (FDA) has approved Guerbet's Elucirem™ (gadopiclenol) for MRI examinations. The agent allows for half the conventional gadolinium dose.
Villepinte, France – Guerbet has received approval from the U.S. Food and Drug Administration (FDA) for its new contrast agent, Elucirem™ (gadopiclenol), intended for use in magnetic resonance imaging (MRI). The FDA's approval, granted following a priority review, signifies a substantial improvement over existing therapies.
Elucirem™ is indicated for adults and children aged 2 years and older for detecting and visualizing lesions with abnormal vascularity in the central nervous system and other body regions. A key feature of Elucirem™ is its ability to achieve diagnostic efficacy at half the conventional gadolinium dose compared to other non-specific GBCAs, aiming to reduce patient exposure to gadolinium.
The approval is based on data from two Phase III clinical trials that demonstrated Elucirem's efficacy and safety. These studies showed that Elucirem at a dose of 0.05 mmol/kg achieved comparable diagnostic benefits to existing agents at 0.1 mmol/kg. The product will be manufactured in both the United States and France.
Guerbet, a pioneer in medical imaging, has a history of developing innovative contrast agents. Elucirem™ has now received U.S. approval and is currently under review by the European Medicines Agency (EMA) via a centralized procedure.