First Batch Following FDA Approval is Manufactured by Liebel-Flarsheimtm Company LLC, a Guerbet Group company, in Raleigh, North Carolina
Eluciremtm has the highest relaxivity compared to other non-specific GBCAs (gadolinium-based contrast agents) 1
Eluciremtm requires only half the gadolinium dose of conventional non-specific GBCAs, addressing practitioners' concerns about gadolinium exposure. 2,3
PRINCETON, N.J., Feb. 2, 2023 /PRNewswire/ -- Guerbet, a global leader in medical imaging with more than 30 years of experience in MRI, announced today the first production batch has been manufactured and released for Eluciremtm (gadopiclenol) injection following FDA approval on September 21, 2022, after priority review.4 This next generation GBCA from Guerbet, highly stable macrocyclic gadolinium-based contrast agent (GBCA), has the highest relaxivity in its class for magnetic resonance imaging (MRI) and is indicated for use in adults and children aged 2 years and older.1,5
"We are in the process of distributing the first batch of Eluciremtm to our partners and are eager to get this digital imaging innovation in the hands of physicians across the county," said Jared Houk, Commercial Vice President, North America at Guerbet. "Releasing the first batch from our production facility in North Carolina is an important moment for everyone at Guerbet and we are proud to see the hard work and dedication come to fruition."
Eluciremtm (Gadopiclenol) injection 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).1
GBCAs improve the contrast between lesions and surrounding tissues by accelerating the relaxation of protons thanks to interaction with gadolinium atoms. Gadopiclenol, the active drug substance of Eluciremtm, has been designed to enable twice as much interaction, resulting in the highest relaxivity among all non-specific GBCAs.5 This allows use at half the conventional gadolinium dose to reveal high quality images.
Elucirem is manufactured by Liebel-Flarsheimtm Company LLC, a Guerbet Group company, in Raleigh, North Carolina and is now available for order.
ELUCIREMtm (gadopiclenol) injection Important Safety Information |
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) See full prescribing information for complete boxed warning Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities.
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Please see complete Important Safety Information below
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 over 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 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 (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) in adult and pediatric patients aged 2 years and older. (refer to the approved USPI for full information). Details on Phase III clinical trials are available on www.ClinicalTrials.gov:
Gadopiclenol is currently in the process of examination by the European Medicines Agency.
Forward-looking statements
This press release may contain statements of a forward-looking nature, based on assumptions and predictions made by the management of 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.
Eluciremtm (gadopiclenol) injection Important Safety Information
Indications and Usage
ELUCIREMtm (gadopiclenol) injection is indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) 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).
Contraindications
History of hypersensitivity reactions to ELUCIREM
Warnings and Precautions
Adverse Reactions:
In clinical trials, the most frequent adverse reactions that occurred in > 0.2% of patients who received ELUCIREM included: injection site pain, headache, nausea, injection site warmth, injection site coldness, dizziness, and localized swelling. Adverse reactions that occurred with a frequency ? 0.2% in patients who received 0.05 mmol/kg BW
ELUCIREM included: maculopapular rash, vomiting, worsened renal impairment, feeling hot, pyrexia, oral paresthesia, dysgeusia, diarrhea, pruritus, allergic dermatitis, erythema, injection site paresthesia, Cystatin C increase, and blood creatinine increase.
Use in Specific Populations
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see the full Prescribing Information, including the Medication Guide, for additional important safety information.
1Elucirem [package insert]. Princeton, NJ: Guerbet LLC; 2022
2Loevner LA, Kolumban B, Hutóczki G, et al. Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System: The PICTURE Randomized Clinical Trial. Investigative Radiology ():10.1097/RLI.0000000000000944, December 19, 2022. | DOI: 10.1097/RLI.0000000000000944
3Data on file (PROMISE trial. GDX-44-011)
4 US FDA. Priority Review. Available at: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review. Accessed August 22, 2022
5 Robic, C., Port, M., Rousseaux, O., Louguet, S., Fretellier, N., Catoen, S., Factor, C., Le Greneur, S., Medina, C., Bourrinet, P., Raynal, I., Idée, J. M., & Corot, C. (2019). Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate With High T1 Relaxivity. Investigative radiology, 54(8), 475?484. https://doi.org/10.1097/RLI.0000000000000563
Contacts:
Guerbet
Leeann Essai, Head of Marketing, North America 609-480-9850/ [email protected]
Syneos Health
Edie Elkinson, Media Relations 310-430-6838/ [email protected]
SOURCE Guerbet
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