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Bracco announces FDA approval of Gadopiclenol Injection

Press releases may be edited for formatting or style | September 22, 2022 MRI
MONROE TOWNSHIP, N.J., Sept. 21, 2022 /PRNewswire/ -- Bracco Diagnostics Inc., the United States (U.S.) subsidiary of Bracco Imaging S.p.A., an innovative world leader in diagnostic imaging, announced today that the U.S. Food and Drug Administration (FDA) has approved Gadopiclenol Injection, a new, highly stable macrocyclic gadolinium-based contrast agent (GBCA), which shows the highest relaxivity compared to all the other GBCAs available today in the United States.i,ii Gadopiclenol Injection will be commercialized by Bracco as VUEWAY (gadopiclenol) injection and VUEWAY (gadopiclenol) Pharmacy Bulk Package. VUEWAY injection is approved for use with MRI in adults and pediatric patients aged 2 years and older to detect and visualize lesions in the central nervous system (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system)ii The approved dose is 0.05 mmol/kg, which was shown to improve the detection and visualization of lesions over unenhanced MRI alone, and to provide similar diagnostic efficacy compared with 0.1 mmol/kg of the lower-relaxivity Gadobutrol injection in the approved indications.iii,iv Please see Indications and Important Safety Information below, including Boxed Warning.

"The approval of Gadopiclenol Injection follows Priority Review, which is granted by the FDA for products that are considered significant improvements in safety or effectiveness when compared to standard optionsv," said Alberto Spinazzi, MD, Chief Medical and Regulatory Officer at Bracco. "This is because Gadopiclenol Injection, to be marketed by Bracco as VUEWAY injection, is a first-of-its-kind MRI agent that delivers the highest relaxivity and highest kinetic stability of all GBCAs on the market today.i Highly stable, clinical studies showed that VUEWAY injection provides effective contrast enhancement and diagnostic efficacy at half the approved dose of Gadobutrol injection and Gadobenate dimeglumine injection, another high-relaxivity agent. iii,iv,vi The positive benefit-risk profile of VUEWAY injection has been demonstrated across a large number of indications, including some for which GBCAs had not previously been approved in the United States."

The pivotal Phase III studies supporting approval of VUEWAY injection were designed as crossover studies, within-patient comparisons of MRI of the CNS or MRI of the body with 0.05 mmol/kg VUEWAY injection or unenhanced MRI alone, and 0.05 mmol/kg Gadopiclenol with 0.1 mmol/kg Gadobutrol in adult patients.iii,iv Even at half dose, MRI with Gadopiclenol was shown to be non-inferior to MRI with the full dose of Gadobutrol. In MRI of the CNS, the quality of visualization obtained with a half-dose of Gadopiclenol was preferred to that of Gadobutrol by all the blinded readers.

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