European Commission Extends Marketing Authorisation for Bracco Imaging's Vueway (Gadopiclenol) to Pediatric Patients Under 2 Years
Tuesday, January 27, 2026
On January 23, 2026, the European Commission amended the Marketing Authorisation for Vueway® (gadopiclenol), extending its use to pediatric patients under 2 years of age, including neonates, across the European Union. This decision follows a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) on December 11, 2025, reinforcing the agent's safety and efficacy in vulnerable populations.[2]
Vueway® is a novel macrocyclic gadolinium-based contrast agent (GBCA) designed for contrast enhancement in Magnetic Resonance Imaging (MRI). Initially approved in the EU in December 2023 for adults and children aged 2 years and older, it aids in detecting and visualizing pathologies in the brain, spine, central nervous system, liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system by improving visualization of blood-brain-barrier disruptions or abnormal vascularity.[2]
The extension addresses a critical need in pediatric diagnostics, where minimizing gadolinium exposure is paramount due to developing tissues and unknown long-term effects of retained gadolinium. Vueway® stands out with the highest longitudinal relaxivity (r1) among approved GBCAs, enabling comparable diagnostic efficacy at half the gadolinium dose of agents like gadobutrol. Multicenter clinical studies, including GDX-44-015, supported this approval, demonstrating efficacy and safety from birth.[2]
"The ability to reduce exposure to gadolinium without affecting the diagnostic performance of MRI examinations is important for all patients receiving GBCAs," stated Alberto Spinazzi, Chief Medical & Regulatory Officer at Bracco Group. "This is particularly important when GBCAs are used in special patient populations, such as neonates, infants and toddlers." This approval underscores Vueway®'s role in precision diagnostics while prioritizing safety in pediatric care.[2]
Bracco Imaging, a global leader in diagnostic imaging, develops contrast agents for X-ray, CT, MRI, and ultrasound, alongside molecular imaging solutions. With over 3,800 employees supporting 100+ countries since 1927, the company emphasizes innovation in radiology. A key collaboration with Guerbet since December 2021 covers gadopiclenol manufacturing and R&D, with both firms commercializing under separate brands post-transition, accelerating access to this high-relaxivity GBCA.[2]
GBCAs like Vueway® leverage gadolinium's magnetic properties to enhance MRI performance, crucial for identifying hard-to-detect pathologies. This extension aligns with EMA guidelines prioritizing low-dose, high-stability agents for pediatrics, potentially setting precedents for future approvals in the EU life sciences sector. Bracco's milestone bolsters the biopharma landscape, enhancing toolkits for European clinicians treating young patients with complex conditions.[2]
The regulatory pathway exemplifies efficient collaboration between CHMP, EMA, and EC, streamlining post-authorization extensions based on robust data. As Vueway® gains approvals in 36 countries, its EU expansion reinforces Europe's leadership in advanced imaging technologies, benefiting manufacturers, regulators, and healthcare providers. This development signals growing emphasis on pediatric-specific innovations in pharma R&D, supply chain optimizations for contrast agents, and strategic positioning in digital health diagnostics within the region.[2]
Industry watchers anticipate ripple effects, including increased R&D investments in macrocyclic GBCAs and partnerships akin to Bracco-Guerbet. For pharma executives, this highlights the value of EMA-aligned trials in expediting market access, while biotech innovators can leverage similar high-relaxivity platforms for competitive edges. Overall, Vueway®'s pediatric nod fortifies EU pharma's innovation ecosystem, promising safer, more effective imaging solutions amid evolving regulatory frameworks.[2]
