Guerbet receives EMA acceptance of Elucirem™ as the Brand Name for Gadopiclenol
VILLEPINTE, France, June 13, 2022 /PRNewswire/ -- Guerbet (EuronextParis: GBT) (ISIN: FR0000032526), a global leader in medical imaging, announces today that Elucirem™, the proposed Guerbet brand name for Gadopiclenol, has been accepted by the European Medicines Agency (EMA). Gadopiclenol is an investigational macrocyclic gadolinium-based contrast agent.
"We are very pleased with the acceptance of Elucirem™ as the brand name for Gadopiclenol. This meaningful step forward aligns with our preparation for its future commercialization in Europe, if approved." said David Hale, Chief Executive Officer of Guerbet Group.
Guerbet announced on the 24th of February 2022 the acceptance of EMA to review the Gadopiclenol Centralized Application for Marketing Authorization.
Gadopiclenol is an investigational macrocyclic gadolinium-based contrast agent for MRI developed by Guerbet's Research & Development team. The efficacy and safety of Gadopiclenol have been evaluated as part of the company's clinical development plan with a view to obtain worldwide marketing authorization. No regulatory authority has evaluated the clinical study data for this product to date. Details on Phase III clinical trials are available on the 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
At Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a global leader in medical imaging, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. As pioneers in contrast products for 95 years, with more than 2,600 employees worldwide, we continuously innovate and devote 8%-10% of our revenue to research and development in five centers in France, Israel, and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B?–?mid caps) and generated €732 million in revenue in 2021. For more information, please visit www.guerbet.com.
This press release may contain statements of a forward-looking nature, based on assumptions and predictions made by the management of the Guerbet group. Various known and unknown risks, uncertainties and other factors could lead to marked differences between the future results, financial situation, development and performance of the company, and the estimates made here. These factors include those mentioned in the public reports of Guerbet, available on its website www.guerbet.com. The company assumes no responsibility whatsoever in relation to the updating of these forward-looking statements, or how they correspond to future events or developments.
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