FDA Approves Gadopiclenol for Contrast-Enhanced Magnetic Resonance Imaging

The FDA has approved gadopiclenol (Elucirem, Guerbet) for use in contrast-enhanced magnetic resonance imaging (MRI). The agent, which was approved following FDA priority review, is a new macrocyclic gadolinium-based contrast (GBCA).

Gadopiclenol, in subsequent contribution with Bracco, is a GBCA with high relaxivity indicated for use in adults and children 2 years of age and older for contrast-enhanced MRI. The agent is used to detect and visualize lesions with abnormal vascularity in the central nervous system (CNS) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).

The approval was based on data from a pair of phase 3 studies that were completed in March 2021. The studies demonstrated that gadopiclenol leads to non-inferior results in brain and body MRI at half the gadolinium dose of gadobutrol. Further, the endpoints were met in terms of the diagnostic benefit of injecting gadopiclenol (0.05 mmol/kg) during MRI examinations. These were based on 2 criteria—the superiority of the examination with gadopiclenol vs the examination with no contrast agent; and the non-inferiority of gadopiclenol (0.05 mmol/kg) vs gadobutrol (0.1 mmol/kg) for the visualization and detection of lesions of the CNS and in the other areas studied.

Additionally, gadopiclenol has been designed with 2 sites for water molecule exchange to increase relaxivity and contrast, which allows use at half the conventional dose of gadolinium compared to other non-specific GBCAs.

No major adverse events (AEs) were reported during the development of the agent, and the AEs reported during the 2 phase 3 studies were similar for both products administered.

The FDA is the first health authority to approve gadopiclenol, and it is currently in the process of examination by the European Medicines Agency via a centralized procedure.

REFERENCE

Guerbet announces U.S. Food and Drug Administration (FDA) approval of Elucirem™ (Gadopiclenol). GlobeNewswire. September 21, 2022. Accessed September 26, 2022. https://www.globenewswire.com/news-release/2022/09/21/2520478/0/en/Guerbet-announces-U-S-Food-and-Drug-Administration-FDA-approval-of-Elucirem-Gadopiclenol.html