US FDA approves Bracco’s Gadopiclenol injection, Vueway

The US FDA has approved Bracco Diagnostics Gadopiclenol injection, a new, highly stable macrocyclic gadolinium-based contrast agent (GBCA), which shows the highest relaxivity compared to all the other GBCAs available in the United States. Bracco Diagnostics is the United States subsidiary of Bracco Imaging, a world leader in diagnostic imaging.

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 paediatric 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). 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.

This approval is timely. A recent shortage in contrast agents has caused physicians to make difficult decisions in their choice of contrast agents for patients. Although this recent shortage was for X-ray contrast agents, shifting of patients to MR contrast resulted in a surge in GBCA use by 50%. The commercialization of Gadopiclenol by both companies will expand access to this first-of-its kind contrast agent by one and a half times, reflecting Bracco’s 30% share of the contrast agent market.

“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 options,” 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. 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. 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.”

No major safety signals were reported during the development of VUEWAY in either adult or paediatric patients, and the adverse events reported during the two Phase III studies were similar for both of the products administered.

Fulvio Renoldi Bracco, Vice-Chairman & CEO of Bracco Imaging, said: “During a year where we will celebrate our 95th anniversary, we are excited to deliver this unique MRI agent to the healthcare community and the patients they serve, a testament to our legacy of innovation. The approval of VUEWAY injection is representative of the commitment of our workforce comprised of more than 300 scientists and engineers who continuously strive to improve the diagnostic performance of medical imaging and patient outcomes.”

The introduction of VUEWAY injection is the result of a strategic, global collaboration between Bracco and Guerbet in both research, development, and manufacturing of the product.

“This strategic collaboration will expand access to this important new contrast agent which has the potential to help improve diagnoses and ultimately improve patient care,” said Cosimo De Pinto, Senior Vice President of Sales and Marketing at Bracco Diagnostics. “By exploring a flexible application of our intellectual property rights, we’ve seen that joining forces has led to meaningful innovation at a faster pace. One of the greatest barriers to health equity and access is overly strict adherence to traditional approaches to knowledge and information sharing. The more we collaborate, the more we unencumber healthcare delivery at moments when it matters most.”

Through this global collaboration, Guerbet and Bracco will commercialize the product independently under different brand names.

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