European Medicines Agency Approves Vueway® for Young Children Under 2

Bracco Imaging's Vueway® Secures Positive Opinion for Pediatric Use

In a significant milestone for pediatric medicine, Bracco Imaging S.p.A., a leading company in diagnostic imaging, announced that on December 11, 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given its endorsement for the use of Vueway® (gadopiclenol) in infants under two years of age. This approval marks an important advancement in providing safe and effective diagnostic tools for young patients.

Vueway® is a macrocyclic gadolinium-based contrast agent (GBCA) currently approved in 36 countries. It plays a crucial role in enhancing Magnetic Resonance Imaging (MRI) examinations, allowing healthcare professionals to detect and diagnose conditions that would otherwise be challenging to visualize. The agent's safety profile and diagnostic performance in conjunction with its established benefits in pediatric usage are particularly noteworthy.

Initially approved for use in adults and children aged two and above in December 2023 within the EU, Vueway® has proven effective in facilitating contrast-enhanced MRI to better discern pathologies associated with disruptions of the blood-brain barrier, abnormal vascularity in the central nervous system, and other critical areas such as the liver, kidneys, and musculoskeletal system. The recent extension to include infants and young children reinforces Vueway®’s established safety and efficacy and addresses a crucial need for pediatric population healthcare.

The latest endorsement follows extensive multicenter clinical studies demonstrating that Vueway® offers comparable diagnostic efficiency to commonly used GBCAs like gadobutrol, but with a significantly lower gadolinium dose. This development plays a vital role in minimizing patient exposure to gadolinium while maintaining MRI examination accuracy.

Dr. Alberto Spinazzi, the Chief Medical Regulatory Officer at Bracco Group, remarked on the significance of this endorsement, particularly highlighting the reduced exposure for delicate patient populations, including neonates and toddlers. He noted: “The ability to lower gadolinium exposure without compromising diagnostic performance is pivotal, especially considering potential long-term effects on maturing brains and body tissues.”

The positive opinion from the CHMP stemmed from study GDX-44-015, underscoring the growing interest and commitment in pediatric healthcare as well as the development of safer imaging solutions for young children.

Gadolinium-based contrast agents (GBCAs) like Vueway® enhance diagnostic imaging techniques through their unique magnetic properties, essential harnessing that promotes effective diagnostics in clinical settings.

Founded in 1927, Bracco Imaging has consistently worked towards improving patient care with innovative solutions in the field of radiology. With more than 3,800 dedicated employees worldwide, Bracco continues to lead advancements in diagnostic imaging, emphasizing the importance of knowledge-sharing and collaboration within healthcare to navigate future challenges.

Together with Guerbet, a strategic partnership initiated in December 2021, Bracco Imaging has accelerated research and development surrounding gadopiclenol, indicative of a forward-thinking approach to pharmaceutical manufacturing and patient care.

The extension of Vueway®'s indications to infants symbolizes a critical leap in addressing pediatric imaging needs, underscoring Bracco Imaging’s ongoing mission to enhance diagnostic capabilities and improve healthcare outcomes for the youngest patients worldwide.