New contrast agent receives FDA approval after competitors collaborate on development
The U.S. Food and Drug Administration has just approved the use of a new gadolinium-based contrast agent for magnetic resonance imaging exams.
The Sept. 21 announcement states that Gadopiclenol Injection—a highly stable macrocyclic gadolinium-based contrast agent (GBCA)—is approved for use in adult and pediatric patients aged 2 years and older during MRI exams. Compared to other GBCAs in the U.S., Gadopiclenol Injection has shown superior relaxivity.
The product will be independently commercialized by both Bracco Diagnostics (as VUEWAY) and Guerbet, as both companies were involved in its development.
"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," Alberto Spinazzi, MD, Chief Medical and Regulatory Officer at Bracco, said in a statement.
Pertaining to the referenced safety measures, Gadopiclenol Injection is approved at a dose of 0.05 mmol/kg, which is half of the dose recommended with the use of Gadobutrol injection and Gadobenate dimeglumine injection.
“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,” Spinazzi continued.
Phase III studies comparing Gadopiclenol to both unenhanced MRI exams and exams using other high-relaxivity agents revealed that the newly approved GBCA can produce results equal or superior to Gadobutrol, even at the lower dose, per the blinded readers. Thus far, there have been no safety alerts with the contrast agent’s use and adverse events reported during two Phase III studies were similar to that of imaging agents currently in clinical use.
Bracco Imaging and Guerbet entered into the collaboration in December of 2021—a move that is intended to accelerate the availability of the product, according to a comment from Cosimo De Pinto, Senior Vice President of Sales and Marketing at Bracco Diagnostics Inc.
"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,” De Pinto said.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She joined Innovate Healthcare in 2021 and has since put her unique expertise to use in her editorial role with Health Imaging.