CHMP recommends EU marketing authorization for Guerbet's Elucirem™
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Elucirem™ (gadopiclenol), a contrast agent for MRI scans, paving the way for EU market authorization.
Villepinte, France – October 12, 2023 – The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the granting of a marketing authorization for Elucirem™ (gadopiclenol) in the European Union. The agent is intended for contrast-enhanced magnetic resonance imaging (MRI) in adults and children aged two years and older.
The European Commission is expected to issue its final decision on the marketing authorization by the end of 2023. Elucirem™ received approval from the United States Food and Drug Administration (FDA) in September 2022.
Elucirem™ is a macrocyclic gadolinium-based contrast agent designed with high relaxivity. Clinical trials indicated that scans using Elucirem™ require half the dose of gadolinium compared to existing non-specific contrast agents, while maintaining diagnostic quality. This could lead to reduced overall gadolinium exposure for patients undergoing MRI procedures.
The CHMP's positive opinion is based on two Phase III clinical trials. These studies demonstrated that Elucirem™ achieved non-inferior diagnostic performance compared to gadobutrol, when administered at half the gadolinium dose. Guerbet stated that this represents a significant innovation for diagnostic imaging in Europe.