Guerbet

CHMP positive opinion

The CHMP issues an opinion
in favour of granting an EU marketing authorisation
for Elucirem (Gadopiclenol)
with the indication of use for magnetic resonance imaging with contrast enhancement in adults
and children aged 2 years and over

If approved by the European Commission, Elucirem (Gadopiclenol) will mark a step forward in innovation in MRI contrast media, thus answering to the Health authorities recommendation and concerns of patients and radiologists in Europe.

An MRI exam with Elucirem requires half the dose of gadolinium compared to existing non-specific contrast products.^{1, 2, 3}

This recommendation is based on two phase III studies available on ClinicalTrials.gov (PICTURE and PROMISE).

Approved by the FDA in September 2022, Elucirem is produced in France and in the USA.

Villepinte, France, 12 october 2023: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion concerning the granting of a marketing authorisation for Elucirem (Gadopiclenol) in the European Union (EU) for use in adults and children aged 2 years and over for MRI with contrast enhancement. The European Commission is expected to issue its decision by the end of 2023. Elucirem was approved by the United States Food and Drug Administration in September 2022.

Elucirem (Gadopiclenol) is a macrocyclic gadolinium-based contrast agent with high relaxivity, indicated in adults and children 2 years and older for magnetic resonance imaging (MRI) with contrast enhancement of the CNS (brain, spine, and surrounding tissues) and several body organs (liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system).

"The efficacy and safety of Gadopiclenol have been assessed as part of the clinical development plan conducted by Guerbet with the aim of obtaining

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¹ PRAC, European Medicines Agency, 2017

² FDA Drug Safety Communication, 2017

³ Brunjes et al. Water Research, 2020

Marketing Authorisations worldwide"
explains Philippe Bourrinet, Vice-President Development, Medical & Regulatory Affairs and Responsible Pharmacist for the Guerbet Group.
"The positive opinion from the CHMP is very good news for radiologists and patients in Europe."

The positive opinion from the CHMP is essentially based on data from two phase III clinical trials completed in March 2021. They demonstrated that Elucirem provided non-inferior results in brain and whole-body MRIs in comparison with Gadobutrol, although half the dose of gadolinium was administered.^{1, 2}.