N.J. company earns FDA approval for much-needed agent used in MRIs

Vueway, produced in collaboration with Guerbet, uses only half of standard amount, which will help with supply chain problems

room with MRI machine.

Supply-chain issues have hampered efforts in diagnostic imaging, as the dye needed to complete the scan has become difficult to obtain — limiting the ability of doctors and MRI centers to complete the procedure.

Bracco Diagnostics, an Italian company that makes its U.S. headquarters in Monroe Township, has found a way to help.

On Thursday, the U.S. Food and Drug Administration gave approval to the Gadopiclenol Injection, a new, highly stable macrocyclic gadolinium-based contrast agent, which has proven to be effective while using just half the standard dosage.

The product, which will be distributed under the name Vueway, was produced in a partnership with Guerbet, a French company that has its U.S. headquarters in Princeton.

The Vueway injection was approved for use with MRI in adults and pediatric patients ages 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).

Dr. Alberto Spinazzi, the chief medical and regulatory officer at Bracco, said the Gadopiclenol 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.

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,” he said.

The introduction of the Vueway injection is the result of a strategic, global collaboration between Bracco and Guerbet in research, development and manufacturing of the product signed in December 2021.

Bracco Diagnostics CEO Jeff Fleming said the collaboration is a win for everyone.

About Bracco Imaging

Bracco Imaging is a 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.

The Bracco Imaging portfolio includes products and solutions for all key diagnostic imaging modalities: X-ray imaging, magnetic resonance imaging, contrast enhanced ultrasound and nuclear medicine through radioactive tracers and novel PET imaging agents. Bracco Imaging has approximately 3,600 employees and operates in more than 100 markets globally.

“This product, with its unique design (and) positive risk benefit profile, has the potential to help improve diagnoses and ultimately improve patient care,” he said. “We’re happy to join forces to do our part to help remove barriers to health equity with Vueway.”

Cosimo De Pinto, senior vice president of sales and marketing at Bracco, said he feels the collaboration will continue to pay off.

“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,” he said. “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 health care delivery at moments when it matters most.”

Through this global collaboration, Guerbet and Bracco will commercialize the product independently under different brand names. A Centralized Application for Marketing Authorization to the European Medicines Agency for Gadopiclenol Injection was submitted earlier this year.