Guerbet announces marketing authorisation approval of Elucirem™ (Gadopiclenol) in the European Union

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Guerbet

11 Dec, 2023, 16:45 GMT

  • The marketing authorisation (MA) for Elucirem™ (Gadopiclenol) was granted to Guerbet by the European Commission based on the positive opinion of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) dated 12 October 2023.
  • For the indications approved in the context of this MA, a MRI examination with Elucirem™ requires half the dose of gadolinium compared to that required with existing nonspecific contrast agents, thus answering a major concern of practitioners about gadolinium exposure.[1],[2],[3]
  • Invented, designed and manufactured by Guerbet, Elucirem™ was approved by the FDA in September 2022. It is produced in France and in the USA. It will be marketed by Guerbet in the European Union in the following forms: vials and prefilled syringes.

VILLEPINTE, France, Dec. 11, 2023 /PRNewswire/ -- Guerbet, global leader in contrast products for medical imaging, announced today that the European Commission has approved the marketing in the European Union (EU) of Elucirem™ (Gadopiclenol), a macrocyclic gadolinium-based contrast agent (GBCA), for use in contrast-enhanced magnetic resonance imaging (MRI).

Born of Guerbet innovation, Elucirem™ (Gadopiclenol) is the gadolinium-based contrast agent with the highest relaxivity, in comparison to other available gadolinium-based contrast agents (GBCA). In the European Union, Elucirem is indicated in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of:

  • the brain, spine, and associated tissues of the central nervous system (CNS);
  • the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.

"Elucirem™ is the first half-dose nonspecific gadolinium-based contrast agent. European radiologists will be able to perform MR examinations with half the conventional dose and thus reduce exposure to gadolinium, particularly in persons requiring repeated examinations," explains Philippe Bourrinet, Vice-President Development, Medical & Regulatory Affairs and Guerbet Group Responsible Pharmacist.

The efficacy and safety of Gadopiclenol were evaluated in the context of Guerbet's clinical development plan designed to obtain marketing authorisations worldwide. To date, the European Commission is the second authority to approve Elucirem™, and evaluation of the dossier is on-going in other countries.

Elucirem™ is produced in France and in the USA. The industrial investment amounts to 22.5 million euros over the past five years. Gadopiclenol active pharmaceutical ingredient and its starting material are manufactured for the USA and Europe on the French sites of Marans (Charente-Maritime) and Lanester (Morbihan). Elucirem™ finished product is then filled in vials at the Aulnay-sous-Bois site (Seine-Saint-Denis, France) for all European countries. Vials for the USA and prefilled syringes for the American and European markets are filled on the Raleigh (USA) site.

"After its approval by the FDA for the American market, the European marketing authorisation for Elucirem™ reinforces our strategic perspective: combining medical innovation and environmental commitment. This authorisation is ground-breaking for Medical Imaging in Europe," concludes David Hale, Guerbet CEO.

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 (The Summary of Product Characteristics (SmPC) will shortly be available on the EMA website). Details of phase III clinical trials are available in the database www.ClinicalTrials.gov: 

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.

About the Guerbet / Bracco Imaging Collaboration

Bracco Imaging and Guerbet in December 2021 entered a worldwide collaboration on Gadopiclenol manufacturing and research and development activities. Gadopiclenol will be commercialized independently under separate brands. Both Guerbet and Bracco Imaging each own valuable intellectual property on Gadopiclenol. Furthermore, after an agreed transition period when Guerbet manufactures Gadopiclenol for both Guerbet and Bracco, both companies will manufacture the Gadopiclenol active ingredient and finished product.

The strategic collaboration is expected to accelerate access to Gadopiclenol and deliver innovation, as well as better care to patients and caregivers alike.

Forward-looking disclaimer

This press release may contain forward-looking statements based on the assumptions and forecasts of Guerbet Group Management. They involve known and unknown risks, uncertainties and other factors, which may result in a material difference between the results, financial situation, outcome and future performance of the Group and those presented in these forward-looking statements. These factors include those mentioned in Guerbet's public documents and available on its website www.guerbet.com. The Group expressly refutes any obligation to publish an update or revise any forward-looking statements contained in this press release in the light of new events or developments.

1. PRAC, European Medicines Agency, 2017
2. FDA Drug Safety Communication, 2017
3. Brunjes et al. Water Research, 2020

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Media contact:
Claire Lauvernier 
Directrice de la Communication, Guerbet
claire.lauvernier@guerbet.com