Bracco announced on September 21 that the U.S. Food and Drug Administration had approved gadopiclenol. Bracco developed gadopiclenol in collaboration with Guerbet, which announced the approval on the same day. Guerbet is selling the agent as Elucirem.
Gadopiclenol is designed to address persistent concerns about gadolinium in patients by enabling clinicians to use half the dose required for other MRI contrast agents. Bracco said that Vueway is a highly stable, macrocyclic GBCA that has higher relaxivity compared with other commercially available MRI contrast agents on the market.
Vueway is approved for use with MRI scans of adults and pediatric patients ages 2 years and older to detect and visualize lesions in the central nervous system, such as the brain, spine, and associated tissues, as well as the body, such as the head and neck, thorax, abdomen, pelvis, and musculoskeletal system.
Bracco noted that the approved dose of Vueway is 0.05 mmol/kg, a level that was demonstrated could improve the detection and visualization of lesions over unenhanced MRI alone. The 0.05-mmol/kg dose level also provided similar diagnostic efficacy compared with 0.1 mmol/kg of gadobutrol, a contrast agent with lower relaxivity.
Bracco and Guerbet developed gadopiclenol under a collaboration agreement signed in December 2021. Both companies have the right to market the contrast agent under their own trade names.
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