Guerbet (FR0000032526 GBT), a global specialist in contrast media and solutions for medical imaging, is delighted to announce the approval by European Commission of a new indication in children from birth for its macrocyclic high-relaxivity gadolinium-based contrast agent, Elucirem™ (gadopiclenol) in the European Union (EU).
Born of Guerbet innovation, Elucirem™ (Gadopiclenol) is the first gadolinium-based contrast agent with the highest relaxivity, in comparison to other available gadolinium-based contrast agents (GBCA) [1]. Elucirem™ was initially approved in the EU in December 2023. It is produced in France and in the USA and is marketed by Guerbet in vials and prefilled syringes.
In the European Union, Elucirem™ is indicated in adults and in children now from birth, for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of:
- the brain, spine, and associated tissues of the central nervous system (CNS);
- the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.
For these indications, an MRI examination with Elucirem™ requires half the conventional dose compared to that required with existing nonspecific contrast agents, thus answering a major concern of practitioners about gadolinium exposure.[2], [3], [4]
” The new indication of Elucirem™ for pediatric patients from birth reflects our commitment to combining medical innovation and patient safety. 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“, explains Valérie Brissart, Guerbet SVP Diagnostic Imaging.
“Children are a very vulnerable group—they’re still developing, and we want to be as safe as possible with everything we do. One key asset of Elucirem™ is that, thanks to its higher relaxivity, we can get very good image quality using only half the conventional gadolinium dose. That makes a real difference in terms of amount of gadolinium injected, especially for these young patients, without losing diagnostic accuracy.”, says Dr. Emilio J Inarejos Clemente, Director and Pediatric radiologist, Hospital Sant Joan de Déu in Barcelona (Spain).
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