(Adnkronos) – Priority Review of the Gadopiclenol NDA granted by the U.S. Food and Drug Administration”

MILAN, March 31, 2022 /PRNewswire/ — 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.

Bracco Imaging S.p.A. (“Bracco Imaging”), part of the Bracco Group, is an innovative world leader delivering end-to-end products and solutions through its comprehensive portfolio across diagnostic imaging modalities. Headquartered in Milan, Italy, Bracco Imaging’s purpose is to improve people’s lives by shaping the future of prevention and precision diagnostic imaging. Bracco Imaging portfolio includes products and solutions for all key diagnostic imaging modalities: X-ray imaging, magnetic resonance imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine. In 2019 Bracco Imaging also enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. The company is active in molecular imaging with innovative agents for positron emission tomography (PET) in patients with suspected recurrent prostate cancer. To learn more, visit www.braccoimaging.com.

Duccio ManettiGlobal Communications Director+39 340 9016191Duccio.Manetti@bracco.com

Micaela ColamasiSenior PR Communication Manager+39 340 9775099Micaela.colamasi@bracco.com

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