EU Approves Guerbet's Elucirem™ Contrast Agent
The European Commission has approved Guerbet's Elucirem™ (gadopiklenol) for marketing within the EU. The agent requires half the dose of gadolinium compared to existing contrast agents in MRI examinations.
Guerbet has received marketing authorisation from the European Commission for its Elucirem™ (gadopiklenol) contrast agent within the European Union. The approval, based on a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in October 2023, allows the use of Elucirem™ in contrast-enhanced magnetic resonance imaging (MRI).
The key benefit of Elucirem™ is its ability to achieve diagnostic clarity with half the dose of gadolinium compared to other non-specific contrast agents. This addresses concerns regarding gadolinium exposure, particularly for patients undergoing repeated examinations.
Invented, designed, and manufactured by Guerbet in France and the USA, Elucirem™ previously received FDA approval in the United States in September 2022. It will be available in the EU in both vials and pre-filled syringes.
Guerbet, a specialist in contrast agents for medical imaging, has invested in the production of Elucirem™, highlighting its significance as the first half-dose non-specific gadolinium-based contrast agent. Regulatory reviews are ongoing in other countries.