Guerbet

CHMP positive opinion - Seite 2

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.

"This positive opinion from the CHMP,
if it results in the granting of a MA by the European Commission
at the end of 2023, will bring European patients and health professionals
an unprecedented innovation in diagnostic imaging."
concludes David Hale, CEO, Guerbet.

About Gadopiclenol
Gadopiclenol, initially invented by Guerbet, with subsequent contribution of Bracco IP, is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity. The efficacy and safety of Gadopiclenol have been evaluated in MRI of the central nervous system, head and neck, thorax, abdomen, pelvis, and musculoskeletal system (for USA reference, please see USA- approved prescribing information here). Details of phase III clinical trials are available in the database www.ClinicalTrials.gov :

• Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) Full Text View - ClinicalTrials.gov
• Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) Full Text View -gov

¹ https://classic.clinicaltrials.gov/ct2/show/NCT03996447?term=gadopicle ...

² https://www.clinicaltrials.gov/ct2/show/NCT03986138?term=Gadopicléno ...

About Guerbet
At Guerbet, we build lasting relationships to enable people to live better lives. This is our Company Purpose (or Raison d’Être in French). We are a global leader in medical imaging, proposing a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging. A pioneer for 95 years in the field of contrast products, with more than 2,600 employees worldwide, we continuously provide innovative solutions and devote 10% of our sales to Research & Development in four centres in France, Israel and the USA. Guerbet (GBT) is listed in compartment B of Euronext Paris and our turnover was 753 million euros in 2022. For more information, please visit www.guerbet.com.