News | Contrast Media | February 16, 2023

First dosage administered at the Hospital of the University of Pennsylvania following FDA approval

First dosage administered at the Hospital of the University of Pennsylvania following FDA approval

February 16, 2023 — Guerbet, a global leader in medical imaging with more than 30 years of experience in MRI, announced the commercial launch and dosing of the first patient with Elucirem (gadopiclenol) injection following FDA approval in 2022. 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.1,4 Elucirem requires only half the gadolinium dose of conventional non-specific GBCAs, addressing practitioners' concerns about gadolinium exposure.2,3 The first dosing took place at the Hospital of the University of Pennsylvania in Philadelphia, PA.

"As a leader in the field of GBCA-based MRI imaging agents, we are proud to mark the first usage of Elucirem. This milestone is the first of many for this novel new product, which has proven to be a promising step forward for the scientific and digital imaging community," said David Hale, Chief Executive Officer at Guerbet.

Elucirem (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  Guerbet received FDA approval of Elucirem (NDA 216986) on September 21, 2022 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.5 

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 Elucirem, has been designed to enable twice as much interaction, resulting in the highest relaxivity among all non-specific GBCAs.4 This allows use at half the conventional gadolinium dose to reveal high quality images.

"Having the ability to use a lower dose of gadolinium, while seeing the diagnostic value and good tolerance during the MRI would be a significant improvement for the practice of neuroradiology," said the study's principal investigator, Dr. Laurie A. Loevner, Division Chief, Neuroradiology and Professor of Radiology at the Perelman School of Medicine at the University of Pennsylvania.

For more information: www.guerbet.com

References:

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 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  
5 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

 

Related Content: 

Efficacy and Safety of Gadopiclenol with Contrast-enhanced MRI of the Central Nervous System Published

Guerbet Announces FDA Approval of Elucirem (Gadopiclenol) for Use in Contrast-enhanced MRI 

Contrast Media Supply Shortage: How and What Now? 

FDA Grants Import Discretion of Bracco’s Iodinated Contrast Medium Iomeron (iomeprol injection) to Address Supply Shortages 

Guerbet to Spotlight the Novel New Drug Elucirem (gadopiclenol) injection at RSNA22 


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