Guerbet Announces US Food and Drug Administration (FDA) Approval of Elucirem™ (Gadopiclenol)

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– FDA approval of Elucirem™ (NDA 216986) was granted after Priority Review, a designation given to drug applications that provide significant improvements in the safety or efficacy of treatment, diagnosis, or prevention serious illnesses compared to available therapies.

– In approved indications, a contrast MRI exam with Elucirem™ requires half the gadolinium dose of existing non-specific GBCAs (gadolinium-based contrast agents), addressing practitioner concerns about gadolinium exposure.[1],[2],[3]

– Elucirem™ (Gadopiclenol) will be produced in United States and France.

– Elucirem™ will be marketed by Guerbet in United States in vial and pre-filled syringe form.

VILLEPINTE, France, September 21, 2022 /PRNewswire/ — Guerbet (FR0000032526GBT)a global leader in medical imaging, today announced that the U.S. Food and Drug Administration (FDA), after priority review, has approved Elucirem™ (Gadopiclenol), a novel macrocyclic GBCA for use in the contrast-enhanced magnetic resonance imaging (MRI).

Elucirem™ (Gadopiclenol) is a novel, high relaxivity, gadolinium-based macrocyclic contrast agent 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 vasculature of the central nervous system (brain, spine and associated tissues) and body (head and neck, thorax, abdomen, pelvis and musculoskeletal system). Please refer to FDA approved prescribing information at [email protected].[4]

Gadopiclenol, the active substance of Elucirem™, has been designed with two water molecule exchange sites to increase relaxivity and contrast, allowing it to be used 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 a view to pending worldwide marketing authorization (see phase III trial results below).

The FDA is the first health authority to approve Elucirem™. It is currently being reviewed by the European Medicines Agency via a centralized procedure.

“As a pioneer in MRI, thanks to the success of our first gadolinium-based macrocyclic contrast agent, we welcome the FDA approval of Elucirem™. This approval allows patients and practitioners to benefit from the innovations provided by Elucirem™.
David HaleGuerbet Group CEO

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 brain and body MRI results at half the gadolinium dose of Gadobutrol.[5],[6] The judgment criteria were met in terms of the diagnostic benefit of the injection of Gadopiclenol (0.05 mmol/kg) during MRI examinations, according to two criteria:

1/ the superiority of the examination with Gadopiclenol compared to the examination without contrast product;
and 2/ the non-inferiority of Gadopiclenol (0.05 mmol/kg) compared to Gadobutrol (0.1 mmol/kg) for visualization and detection of lesions in the central nervous system and in the other anatomical areas studied.

No major safety signal was reported during the development of Gadopiclenol and the adverse effects reported during the two Phase III studies were similar for the two products administered. Please refer to FDA approved prescribing information at [email protected].[7]

Details of these two clinical trials are available on the www.ClinicalTrials.gov database:

Production of Elucirem™ (Gadopiclenol)

Production of Gadopiclenol will take place at one Guerbet plant in the United States and at three French plants. These three French factories employ around 700 people in production and in research and development.

About gadopiclenol

Gadopiclenol, originally invented by Guerbet with subsequent intellectual property input from Bracco, is a novel high relaxivity gadolinium-based macrocyclic contrast agent (GBCA). The efficacy and safety of gadopiclenol were assessed by MRI of the central nervous system, head and neck, thorax, abdomen, pelvis, and musculoskeletal system (refer to USPI approved for complete information). Details of phase III clinical trials are available at www.ClinicalTrials.gov:

Gadopiclenol is currently under review by the European Medicines Agency.

About Guerbet

At Guerbet, we build lasting relationships to enable people to live better. This is our goal. We are a global leader in medical imaging, offering a full range of pharmaceuticals, medical devices, and digital and AI solutions for diagnostic and interventional imaging. Pioneers in contrast products for 95 years, with more than 2,600 employees worldwide, we are constantly innovating and devote 8 to 10% of our turnover to research and development in five France, Israeland United States. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated revenue of €732 million in 2021. For more information, please visit www.guerbet.com.

About the collaboration between Guerbet and Bracco Imaging

Guerbet and Bracco Imaging entered into December 2021 in a global collaboration on gadopiclenol manufacturing and research and development indicate. Gadopiclenol will be marketed independently under separate brand names. Guerbet and Bracco Imaging each own valuable intellectual property on Gadopiclenol. In addition, after an agreed transition period during which Guerbet will manufacture Gadopiclenol for Guerbet and Bracco Imaging, the two companies will manufacture the active ingredient and the finished product of Gadopiclenol.

Forward-looking statements

This press release may contain forward-looking statements, based on assumptions and forecasts made by the management of the Guerbet group. Various known and unknown risks, uncertainties and other factors could lead to material differences between the future results, financial situation, development and performance of the company and the estimates made here. These factors include those mentioned in Guerbet’s public reports, available on its website. www.guerbet.com. The company does not assume any responsibility for updating these forward-looking statements or for their correspondence with future events or developments.

1. PRAC, European Medicines Agency, 2017
2. FDA Communication on Drug Safety, 2017
3. Brunjes et al. Water Research, 2020
4. https://www.accessdata.fda.gov
5. https://www.clinicaltrials.gov/ct2/show/NCT03996447?term=Gadopiclenol&draw=2&rank=2
6. https://www.clinicaltrials.gov/ct2/show/NCT03986138?term=Gadopiclenol&draw=2&rank=1
seven. https://www.accessdata.fda.gov

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ACTIFIN – Mathias Jordan
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SOURCE Guerbet

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