- 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:
- 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
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
Logo:
https://mma.prnewswire.com/media/1776100/3402648/guerbet_Logo.jpg
Media contact:
Claire Lauvernier
Directrice de la Communication, Guerbet
claire.lauvernier@guerbet.com
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