#Italy #Milan #Bracco Imaging #VUEWAY #gadopiclenol

European Commission Extends Vueway® Approval for Pediatric Use

In a significant advancement for diagnostic imaging, the European Commission (EC) has granted an extension of the marketing authorization for Vueway® (gadopiclenol) to include pediatric patients under the age of 2. This decision was made on January 23, 2026, reflecting the positive evaluations by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The updated indication is a landmark for Bracco Imaging S.p.A., a company at the forefront of diagnostic imaging technology.

What is Vueway®?

Vueway® is a cutting-edge macrocyclic gadolinium-based contrast agent (GBCA) that has gained approval in 36 countries around the world. It plays a crucial role in enhancing magnetic resonance imaging (MRI) examinations, allowing healthcare professionals to detect conditions that might otherwise go unnoticed. The agent was initially approved for use in adults and children aged 2 years and older in December 2023, specifically for contrast-enhanced MRIs facilitating the visualization of multiple pathologies related to the central nervous system, liver, kidneys, and more.

Significance of the Extension

The recent extension of Vueway®'s marketing authorization to pediatric patients, including infants and neonates, marks a significant milestone. The CHMP adopted this positive opinion after rigorous studies demonstrated that Vueway® exhibits an excellent safety profile and diagnostic efficacy, which is vital for this vulnerable patient group. The new approval underscores the importance of reducing gadolinium exposure, particularly in young patients whose brains and bodies are still developing.

Alberto Spinazzi, the Chief Medical Regulatory Officer at Bracco Group, highlighted the critical nature of this approval, stating, "The ability to reduce gadolinium exposure without compromising MRI diagnostic performance is essential for patients, especially among neonates and infants. This extension of use caters to an urgent clinical need."

Clinical Benefits of Vueway®

Vueway® has been recognized for its high stability and superior imaging characteristics, offering the highest longitudinal relaxivity (r1) among currently approved GBCAs. Extensive multicenter clinical studies indicate that Vueway® provides comparable diagnostic outcomes at just half the gadolinium dose of gadobutrol, a widely utilized GBCA. This lower-dose approach significantly mitigates patient exposure to gadolinium, which is particularly advantageous in pediatric imaging.

The safety of gadolinium-based contrast agents is a well-discussed subject, and Bracco Imaging's commitment to continuous research has solidified its reputation as a pioneer in the field. The approved clinical outcomes stem from the GDX-44-015 study, which provided vital insights into the efficacy and safety of Vueway®.

A Commitment to Educational Advancement

Bracco Imaging is not only focused on providing innovative solutions but also on advancing the field of radiology through education. The company encourages sharing knowledge, fostering future leaders, and connecting current practices with tomorrow’s advancements. With a history spanning over 95 years, Bracco Imaging continues to innovate and support patients worldwide, emphasizing their commitment to enhancing diagnostic imaging.

Conclusion

The extension of Vueway®'s marketing authorization to pediatric patients under two years old is a groundbreaking development in the realm of diagnostic imaging. As healthcare providers gain access to advanced imaging capabilities that prioritize patient safety, the importance of continuous innovation in medical technology remains evident. Bracco Imaging's dedication to shaping the future of diagnostic imaging ensures that advancements will keep emerging, ultimately improving healthcare outcomes for even the youngest patients.

For more information on Bracco Imaging and their products, visit Bracco Imaging.