Pharma Focus Europe

European Commission Approves Marketing Authorization for Vueway® (Gadopiclenol)

Saturday, December 23, 2023

Bracco Imaging SpA has obtained marketing approval from the European Commission for Vueway® (gadopiclenol), a new contrast agent for magnetic resonance (MR) imaging. The approval, backed by the Committee for Medicinal Products for Human Use (CHMP) and the European Medicines Agency (EMA), paves the way for Vueway® to be introduced to the German market by the second quarter of 2024.

Vueway® is an innovative macrocyclic gadolinium-based contrast agent (GBCA) developed for contrast-enhanced MR imaging, boasting high stability. It addresses the EMA's directive to minimize gadolinium usage and exhibits superior effectiveness compared to existing extracellular contrast agents in Germany. This enhanced efficacy allows for a substantial reduction in the gadolinium dose, leading to lower patient exposure and reduced environmental impact. After receiving approval in the USA in 2022, Vueway® is now authorized in the European Union for contrast-enhanced MR imaging in adults and children aged 2 years and older. It aids in detecting pathologies involving blood-brain barrier disruption and vascular anomalies in various areas, including the brain, spine, central nervous system, liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.

The positive CHMP opinion and EMA recommendation that led to EU marketing authorization are based on the findings of two extensive, randomized, double-blind, cross-over studies—PICTURE 1 and PROMISE 2. Over 500 adult patients participated in these studies, comparing the safety and efficacy of 0.05 mmol/kg gadopiclenol (Vueway®) and 0.1 mmol/kg gadobutrol. PICTURE 1 demonstrated equivalent diagnostic effectiveness for MRI scanning of the central nervous system, while PROMISE 2 yielded similar results for MRI of the head and neck, thorax, breast, liver, pancreas, pelvic organs, and musculoskeletal system.

Fulvio Renoldi Bracco, CEO of Bracco Imaging SpA, expressed excitement about this groundbreaking development, emphasizing its significance in advancing patient care. The innovation is expected to benefit medical professionals and, more importantly, patients undergoing MRI examinations, especially those dealing with chronic diseases.



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