CHMP positive for Elucirem (gadopiclenol) in the European Union (EU) for use in adults and children aged 2 years and over for MRI with contrast enhancement – Guerbet S.A + Bracco
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) (Vueway in the US) 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 FDA 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 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. The assessment criteria were met in terms of diagnostic benefit of the MRI examination with injection of gadopiclenol (0.05 mmol/kg) based on two criteria: – the superiority of the examination with contrast product versus no contrast product, – the non-inferiority of gadopiclenol (0.05 mmol/kg) compared to Gadobutrol (0.1 mmol/kg), for the visualisation and detection of lesions of the central nervous system and other anatomical territories studied.