News | Contrast Media | May 15, 2023

Guerbet Announces ACR Committee on Drugs and Contrast Media Classifies Elucirem (Gadopiclenol) Injection a Group II Agent

Elucirem, a novel new macrocyclic GBCA for use in contrast-enhanced magnetic resonance imaging (MRI), has the highest relaxivity compared to other non-specific GBCAs (gadolinium-based contrast agents)

May 15, 2023 — Guerbet, a global leader in medical imaging with more than 30 years of experience in MRI, announced that based on the most recent scientific and clinical evidence, the ACR Committee on Drugs and Contrast Media has classified Elucirem (gadopiclenol) as a Group II agent.⁶ 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

"This new classification from the ACR is a real game changer for the future of Elucirem," said Jared Houk, Commercial Vice President at Guerbet. "This is an important moment for our team as it really shows the benefit of this product and its potential in the market."

The classification states that gadopiclenol "demonstrates kinetic stability and a long dissociation half-life that are comparable to other Group II macrocyclic agents. Based on the most recent scientific and clinical evidence, the ACR Committee on Drugs and Contrast Media considers the risk of NSF among patients exposed to standard or lower than standard doses of Gadopiclenol is sufficiently low or possibly nonexistent such that it has been classified as a Group II agent."⁶

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.

Elucirem is manufactured by Liebel-Flarsheim Company LLC, a Guerbet Group company, in Raleigh, North Carolina.

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
⁶ACR Committee on Drugs and Contrast Media. ACR Manual on Contrast Media. April 2023.