Guerbet, a global medical imaging company, has 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).
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September 21, 2022 – Guerbet, a global medical imaging company, has 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).
According to a news release announcing the FDA approval, the company, based in Villepinte, France, reported:
FDA approval of Elucirem (NDA 216986) was granted 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.
In the approved indications, a contrast-enhanced MRI examination using Elucirem requires half the gadolinium dose of existing non-specific GBCAs (gadolinium-based contrast agents), addressing practitioners’ concerns about gadolinium exposure.(1,2,3)
Elucirem (Gadopiclenol) will be produced in the United States and France. The production of Gadopiclenol will take place at one Guerbet’s United States and at three French plants. Those three French plants employ approximately 700 people in production and research and development. Additionally, the company noted that Elucirem will be marketed by Guerbet in the United States in bottle and pre-filled syringe form.
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). Please refer to the FDA approved Prescribing Information on Drugs@FDA. (4)
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. Gadopiclenol is currently in the process of examination by the European Medicines Agency.