Guerbet announces U.S. Food and Drug Administration (FDA) approval
of Elucirem™ (Gadopiclenol)
Guerbet announces U.S. Food and Drug
Administration (FDA) approval of Elucirem™
(Gadopiclenol)
- FDA approval of EluciremTM (NDA 216986) was granted after
priority review, a designation assigned to applications for drugs
that provide significant improvements in the safety or
effectiveness of the treatment, diagnosis, or prevention of serious
conditions compared to available therapies.
- In the approved indications, a contrast-enhanced MRI
examination using Elucirem™ requires half the gadolinium dose of
existing non-specific GBCAs (gadolinium-based contrast agents),
addressing practitioners’ concerns about gadolinium
exposure.1,2,3
- EluciremTM (Gadopiclenol) will be produced in the United States
and France.
- EluciremTM will be marketed by Guerbet in the United States in
bottle and pre-filled syringe form.
Villepinte, France, September 21st 2022
– Guerbet (FR0000032526 GBT), a global leader in medical
imaging, announced today that the U.S. Food and Drug Administration
(FDA) after priority review, approved Elucirem™ (Gadopiclenol), a
new macrocyclic GBCA for use in contrast-enhanced magnetic
resonance imaging (MRI).
Elucirem™ (Gadopiclenol) is a new macrocyclic
gadolinium-based contrast agent with high relaxivity indicated for
use in adults and children aged 2 years and older, for
contrast-enhanced magnetic resonance imaging (MRI). The product is
used to detect and visualize lesions with abnormal vascularity in
the central nervous system (brain, spine and associated tissues)
and the body (head and neck, thorax, abdomen, pelvis, and
musculoskeletal system). Please refer to the FDA approved
Prescribing Information on Drugs@FDA.4
Gadopiclenol, the active substance of
EluciremTM, has been designed with two sites for water molecule
exchange to increase relaxivity and contrast, allowing to use it at
half the conventional dose of gadolinium compared to other
non-specific GBCAs.
The efficacy and safety of Gadopiclenol have
been assessed as part of Guerbet’s clinical development plan, with
marketing authorization being targeted worldwide (cf. phase III
trial results below).The FDA is the first health authority to have
approved EluciremTM. It is currently in the
process of examination by the European Medicines Agency via a
centralized procedure.
“As a pioneer in MR imaging, thanks to
the success of our first gadolinium-based macrocyclic contrast
agent, we are delighted with the FDA approval of Elucirem™. This
approval allows patients and practitioners to benefit from the
innovations brought by Elucirem™”
David Hale, Chief Executive Officer of Guerbet
Group
Phase III clinical trials for
Elucirem™
The approval was primarily based on data from
two Phase III studies completed in March 2021 which demonstrated
that Elucirem™ leads to non-inferior results in brain and body MRI
at half the gadolinium dose of Gadobutrol.5,6 The endpoints were
met in terms of the diagnostic benefit of injecting Gadopiclenol
(0.05 mmol/kg) during MRI examinations, based on two criteria:
1/ the superiority of the examination with Gadopiclenol compared to
the examination with no contrast agent;and 2/ the non-inferiority
of Gadopiclenol (0.05 mmol/kg) compared to Gadobutrol
(0.1 mmol/kg) for the visualization and detection of lesions
of the central nervous system and in the other anatomical areas
studied.
No major safety signals were reported during the
development of Gadopiclenol, and the adverse reactions reported
during the two-Phase III studies were similar for both products
administered. Please refer to the FDA approved Prescribing
Information on Drugs@FDA.7
Details on these two clinical trials are
available in the www.ClinicalTrials.gov database:
- 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 - ClinicalTrials.gov
Production of Elucirem™
(Gadopiclenol)
The production of Gadopiclenol will take place
at one Guerbet’s US and at three French plants. Those three French
plants employ approximately 700 people in production and research
& development.
About GadopiclenolGadopiclenol,
initially invented by Guerbet with subsequent contribution of
Bracco intellectual property, 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 (refer to the approved USPI for full information). Details
on Phase III clinical trials are available on
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 - ClinicalTrials.gov
Gadopiclenol is currently in the process of
examination by the European Medicines Agency.
About GuerbetAt 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.
About Guerbet and Bracco Imaging
CollaborationGuerbet and Bracco Imaging entered in
December 2021 into a worldwide collaboration on Gadopiclenol
manufacturing and research and development indicate. 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
Imaging, both companies will manufacture Gadopiclenol active
ingredient and finished product.
Forward-looking statementsThis
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 performances 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.
[1] PRAC, European Medicines Agency, 2017
2 FDA Drug Safety Communication, 2017
3 Brunjes et al. Water Research, 2020
4 https://www.accessdata.fda.gov
5
https://www.clinicaltrials.gov/ct2/show/NCT03996447?term=Gadopiclénol&draw=2&rank=2
6
https://www.clinicaltrials.gov/ct2/show/NCT03986138?term=Gadopiclénol&draw=2&rank=1
7 https://www.accessdata.fda.gov
Contacts:
GuerbetClaire Lauvernier, Group Communication Director
+33.6.79.52.11.88 / claire.lauvernier@guerbet.com
ActifinMathias Jordan, Media Relations +33.1.56.88.11.26 /
mjordan@actifin.fr
- CL FV Guerbet_PR Elucirem AMM FDA UK V9
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