EMA Committee Recommends Vueway for Pediatric Patients Under 2 Years, Addressing Critical Unmet Need in Neonatal Imaging
核心洞察
The European Medicines Agency (搜索)'s CHMP (搜索) adopted a positive opinion on December 11, 2025, recommending extension of Vueway (gadopiclenol) approval to pediatric patients below 2 years of age, including neonates.
Vueway is a macrocyclic gadolinium-based contrast agent with the highest longitudinal relaxivity among approved GBCAs, delivering comparable diagnostic efficacy at half the gadolinium dose of gadobutrol.
The recommendation addresses a critical need for reduced gadolinium exposure in vulnerable populations whose brains and body tissues are still maturing, with unknown long-term effects of retained gadolinium.
The European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use (CHMP (搜索)) has adopted a positive opinion recommending the extension of Vueway (gadopiclenol) approval to pediatric patients below 2 years of age, including neonates. The December 11, 2025 recommendation represents a significant advancement in pediatric diagnostic imaging, addressing a critical unmet medical need for safer contrast agents in vulnerable patient populations.
Regulatory Milestone for Pediatric Imaging
Vueway, a macrocyclic gadolinium-based contrast agent (GBCA) developed by Bracco Imaging S.p.A., was initially approved in the European Union in December 2023 for use in adults and children aged 2 years and older. The agent is currently approved in 36 countries and provides contrast enhancement in Magnetic Resonance Imaging (MRI) examinations to help physicians detect pathologies that would otherwise be undetectable.
The CHMP (搜索)'s positive opinion extends the existing indications to infants and young children, including neonates, reinforcing the agent's established safety and diagnostic performance profile. The current approved indications include contrast-enhanced MRI to improve detection and visualization of pathologies with disruption of the blood-brain-barrier and abnormal vascularity of the brain, spine, and associated tissues of the central nervous system, as well as contrast-enhanced MRI of the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.
Superior Relaxivity Profile Enables Dose Reduction
Vueway distinguishes itself through its highly stable, macrocyclic structure and the highest values of longitudinal relaxivity (r1) among all currently approved GBCAs. Large, multicenter clinical studies have demonstrated that Vueway delivers comparable diagnostic efficacy at half the gadolinium dose of gadobutrol, a GBCA widely used in clinical practice worldwide.
This dose reduction capability offers important benefits in terms of reduced patient exposure to gadolinium, a consideration that becomes particularly critical in pediatric populations. "The ability to reduce exposure to gadolinium without affecting the diagnostic performance of MRI examinations is important for all patients receiving GBCAs," said Alberto Spinazzi, Chief Medical & Regulatory Officer, Bracco Group.
Addressing Pediatric Safety Concerns
The extension to neonatal and infant populations addresses specific safety considerations unique to these vulnerable patient groups. "This is particularly important when GBCAs have to be used in special patient populations, such as neonates, infants and toddlers, whose brains and body tissues are still maturing, and potential long-term effects of retained gadolinium are still unknown," Spinazzi explained. "Therefore, the positive CHMP (搜索) opinion on the extension of the use of Vueway from birth addresses a critical need."
The positive CHMP (搜索) opinion was based on results from study GDX-44-015, which evaluated the safety and efficacy of gadopiclenol in the pediatric population under 2 years of age. The benefit-risk ratio of Vueway was considered positive in children from birth, supporting the regulatory recommendation.
Strategic Collaboration and Market Access
Bracco Imaging's development of Vueway is supported by a worldwide collaboration with Guerbet established in December 2021, covering gadopiclenol manufacturing and research and development activities. The strategic partnership involves shared intellectual property rights and manufacturing responsibilities, with both companies expected to manufacture the active ingredient and finished product following an agreed transition period.
The collaboration is designed to accelerate patient access to gadopiclenol and deliver innovation to improve care for patients and caregivers. Bracco Imaging, founded in 1927, has grown to more than 3,800 employees and supports patients and radiology professionals in over 100 countries through its comprehensive portfolio of diagnostic imaging products.