Guerbet Gains European Approval for Pediatric Use of Elucirem™ Contrast Agent
The European Commission has approved Guerbet's Elucirem™ (gadopiclenol) contrast agent for a new indication in pediatric patients from birth. This expands its use in magnetic resonance imaging (MRI) across the EU.
Villepinte, France – Guerbet, a global specialist in contrast media and imaging solutions, announced today that the European Commission has approved a new indication for its macrocyclic, high-relaxivity gadolinium-based contrast agent (GBCA), Elucirem™ (gadopiclenol). The approval extends its use to pediatric patients from birth within the European Union.
Elucirem™, first approved in the EU in December 2023, is notable for its high relaxivity, allowing for half the conventional dose compared to non-specific contrast agents. This key feature aims to reduce gadolinium exposure for patients, a significant concern, particularly for pediatric populations requiring serial imaging.
The expanded indication allows for enhanced detection and visualization of pathologies with disruption of the blood-brain barrier and/or abnormal vascularity. This applies to MRI examinations of the brain, spine, liver, kidneys, and other organs and musculoskeletal systems.
"The new indication of Elucirem™ for pediatric patients from birth reflects our commitment to combining medical innovation and patient safety," said Valérie Brissart, Guerbet SVP Diagnostic Imaging. "European radiologists will be able to perform contrast-enhanced MR imaging using half the conventional gadolinium dose, which is critical for patients, especially those requiring serial MRI examinations during their lifetime, as it reduces cumulative gadolinium exposure."
Guerbet, which produces Elucirem™ in France and the USA, markets the agent in vials and prefilled syringes. The approval strengthens the company's offering in the diagnostic imaging market, particularly for pediatric applications.