FDA Approves Lower Dose Gadolinium-Based Contrast Agent

Elucirem requires half the gadolinium dose of existing gadolinium-based contrast agents, addressing practitioners’ concerns about gadolinium exposure during MRIs. It will be available in bottle and pre-filled syringe form.

The FDA has approved Guerbet’s Elucirem (gadopiclenol), a new macrocyclic gadolinium-based contrast agent for use with magnetic resonance imaging (MRI). It is approved for use in adults and children aged 2 years and older 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.

Elucirem will be marketed by Guerbet in the United States in bottle and pre-filled syringe form. It has been designed to allow it to be used at half the conventional dose of gadolinium compared with other non-specific gadolinium-based contrast agents.

There has been concern among practitioners about the use of the contrast agent. A rare but serious adverse event, called nephrogenic systemic fibrosis (NSF), has been seen in a subgroup of patients with preexisting kidney failure. Concern revolves around the risk of cumulative exposure for repeat MRIs using these contrast agents. Current recommendations include limiting the volume of gadolinium-based contrast agents, increasing patient education, and doing an institutional outcome review.

The approval is based on data from two phase 3 studies completed in March 2021, which demonstrated that Elucirem leads to non-inferior results in brain and body MRI at half the gadolinium dose of gadobutrol. The endpoints were met in terms of the diagnostic benefit of injecting gadopiclenol, based on two criteria: the superiority of the examination with gadopiclenol compared with the examination with no contrast agent; and the non-inferiority of gadopiclenol (0.05 mmol/kg) compared with gadobutrol (0.1 mmol/kg) for the visualization and detection of lesions of the central nervous system and in the other anatomical areas studied.

The France-based Guerbet submitted applications for approval to both the FDA and the European Medicine Agency in March 2022.