Guerbet announced that the U.S. Food and Drug Administration (FDA) after priority review, approved Elucirem (Gadopiclenol), a new macrocyclic GBCA for use in contrast-enhanced magnetic resonance imaging (MRI). Elucirem (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent with high relaxivity indicated for
use in adults and children aged 2 years and older, for contrast-enhanced magnetic resonance imaging (MRI). The
product 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). Gadopiclenol, the active substance of Elucirem, has been designed with two sites for water molecule exchange
to increase relaxivity and contrast, allowing to use it at half the conventional dose of gadolinium compared to
other non-specific GBCAs. The efficacy and safety of Gadopiclenol have been assessed as part of GuerbetÆs clinical development plan, with
marketing authorization being targeted worldwide. The FDA is the first health authority to have approved Elucirem. It is currently in the process of examination by the European Medicines Agency via a centralized procedure. The approval was primarily based on data from two Phase III 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.5,6 The endpoints were met in terms of the diagnostic benefit of injecting Gadopiclenol (0.05ámmol/kg) during MRI examinations, based on two criteria: 1/the superiority of the examination with Gadopiclenol compared to the examination with no contrast agent; and 2/the non-inferiority of Gadopiclenol (0.05ámmol/kg) compared to Gadobutrol (0.1ámmol/kg) for the visualization and detection of lesions of the central nervous system and in the other anatomical areas studied.