- FDA approval of Elucirem™ (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]
- Elucirem™ (Gadopiclenol) will be produced in the United States and France.
- Elucirem™ will be marketed by Guerbet in the United States in bottle and pre-filled
syringe form.
VILLEPINTE, France, Sept. 21,
2022 /PRNewswire/ -- 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 Elucirem™, 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
Elucirem™. 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 Gadopiclenol
Gadopiclenol, 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 Guerbet
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.
About Guerbet and Bracco Imaging Collaboration
Guerbet 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 statements
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 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
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Media relations:
Guerbet Global
ACTIFIN – Mathias Jordan
+33 (0)1 56 88 11 26
mjordan@actifin.fr
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