The CHMP issues an opinion in favour of
granting an EU marketing authorisation for Elucirem™
(Gadopiclenol)with the indication of use
for magnetic resonance imaging with contrast
enhancement in adults and children aged 2 years
and over
If approved by the European Commission, Elucirem™
(Gadopiclenol) will mark a step forward in innovation in MRI
contrast media, thus answering to the Health authorities
recommendation and concerns of patients and radiologists in
Europe.
An MRI exam with Elucirem™ requires half the dose
of gadolinium compared to existing non-specific contrast
products.1, 2, 3
This recommendation is based on two phase III
studies available on ClinicalTrials.gov (PICTURE and PROMISE).
Approved by the FDA in September 2022, Elucirem™
is produced in France and in the USA.
Villepinte, France, 12 october
2023: The Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has issued a positive opinion concerning the granting of a
marketing authorisation for Elucirem™ (Gadopiclenol) in the
European Union (EU) for use in adults and children aged 2 years and
over for MRI with contrast enhancement. The European Commission is
expected to issue its decision by the end of 2023. Elucirem™ was
approved by the United States Food and Drug Administration in
September 2022.
Elucirem™ (Gadopiclenol) is a macrocyclic gadolinium-based
contrast agent with high relaxivity, indicated in adults and
children 2 years and older for magnetic resonance imaging (MRI)
with contrast enhancement of the CNS (brain, spine, and surrounding
tissues) and several body organs (liver, kidney, pancreas, breast,
lung, prostate, and musculoskeletal system).
"The efficacy and safety of Gadopiclenol have been
assessed as part of the clinical development plan conducted by
Guerbet with the aim of obtaining
1 PRAC, European Medicines Agency, 2017
2 FDA Drug Safety Communication, 2017
3 Brunjes et al. Water Research, 2020
Marketing Authorisations
worldwide" explains Philippe Bourrinet,
Vice-President Development, Medical & Regulatory Affairs and
Responsible Pharmacist for the Guerbet Group. "The positive
opinion from the CHMP is very good news for radiologists and
patients in Europe."
The positive opinion from the CHMP is essentially based on data
from two phase III clinical trials completed in March 2021. They
demonstrated that Elucirem™ provided non-inferior results in brain
and whole-body MRIs in comparison with Gadobutrol, although half
the dose of gadolinium was administered.1, 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 GadopiclenolGadopiclenol,
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=gadopiclenol&draw=2&rank=2
2
https://www.clinicaltrials.gov/ct2/show/NCT03986138?term=Gadopiclénol&draw=2&rank=1
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
CollaborationBracco 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 disclaimerThis
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.
Press contacts :
GuerbetClaire Lauvernier, Communications Director
+33.6.79.52.11.88 / claire.lauvernier@guerbet.com
LauMaMathilde Birembaux, +33.6.82.34.25.38 /
mathilde.birembaux@lauma-communication.comLaurent Mignon,
+33.6.10.17.54.84 / laurent.mignon@lauma-communication.com
- CP - CHMP positive opinion - English - Final
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