The U.S. Food and Drug Administration (FDA) has granted a priority review of a new drug application for a macrocyclic gadolinium-based contrast agent (GBCA) for MRI, gadopiclenol, being developed by Bracco Imaging and Guerbet.
Bracco has been working with Guebert on gadopiclenol. The two firms will market the contrast agent independently under different brand names, while also collaborating on manufacturing, research and development programs, and activities to obtain regulatory approvals. Guebert recently submitted a marketing authorization application for the product in the European Union.
Bracco said gadopiclenol has high relaxivity, with its efficacy and safety being evaluated in MRI of the central nervous system and MRI of the head and neck, thorax, breast, abdomen, pelvis, and musculoskeletal system.
No regulatory authority has completed evaluation of the nonclinical and clinical data deriving from gadopiclenol's development.
