Gadopiclenol: another milestone achieved
Bracco is very excited about the Priority Review granted by the U.S. Food and Drug Administration (FDA) to the New Drug Application (NDA) of the investigational high-relaxivity, macrocyclic gadolinium-based contrast agent (GBCA) Gadopiclenol, which follows the acceptance of the Marketing Authorization Application (MAA) made by Guerbet for the product in the European Union, as well as a duplicate MAA by Bracco.
"A Priority Review designation means that FDA will take action months earlier compared with standard applications, and is a recognition by the U.S. Agency about the possible improvements in safety and/or effectiveness that Gadopiclenol, if approved, could provide to patients and to MRI healthcare professionals" says Fulvio Renoldi Bracco, Vice-Chairman of the Board & CEO of Bracco Imaging, a world leader in diagnostic imaging. "It is a very important milestone in the collaboration between Guerbet and Bracco to bring this new MR agent to clinical fruition in the earliest possible time."
Bracco Imaging and Guerbet have a worldwide collaboration on Gadopiclenol, an investigational macrocyclic gadolinium-based contrast agent (GBCA). The two companies will be marketing the product independently under different brand names, while also collaborating on manufacturing, as well as research and development programs and activities to obtain regulatory approvals.
Bracco is looking forward to celebrating in June its 95th anniversary, a major milestone for a company that has constantly brought innovation to the market and will continue to do so with breakthrough products. Bracco's mission has always been innovation-driven, confirming its commitment to strengthening a leadership position in the diagnostic imaging space.
Gadopiclenol is an investigational macrocyclic GBCA with high relaxivity. The efficacy and safety of Gadopiclenol have been evaluated in MRI of the Central Nervous System and MRI of the head and neck, thorax, breast, abdomen, pelvis, musculoskeletal system. No Regulatory Authority has completed evaluation of the nonclinical and clinical data deriving from the development of the product. Both Guerbet and Bracco Imaging own valuable intellectual property relating to Gadopiclenol.