Bracco Imaging SpA, a global innovative leader offering comprehensive products and solutions across a comprehensive portfolio including precision diagnostic imaging modalities, today received notification that the The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Vueway® (Gadopiclenol) injectable solution for magnetic resonance imaging (MRI) for use in adult and pediatric patients from of 2 years of age with magnetic resonance imaging (MRI) of the CNS (brain, spine and surrounding tissues) and various body organs (liver, kidney, pancreas, breast, lung, prostate and musculoskeletal system). The European Commission is expected to issue its decision at the end of 2023.
Vueway® (Gadopiclenol), is a new gadolinium-based macrocyclic contrast agent (GBCA), very stable and with the highest relaxivity among all other GBCAs currently marketed 1, so its approved dose is exactly half of that approved for other macrocyclic GBCAs for similar indications 2 . It was approved by the United States Food and Drug Administration (FDA) in September 2022.
"The high relaxivity of Vueway® has been shown to allow an improvement in its risk-benefit profile by reducing exposure without compromising imaging performance," noted Alberto Spinazzi , MD, chief medical and regulatory officer at Bracco Imaging. "Vueway® will provide healthcare professionals with an important new option for their patients, as well as the environment. We look forward to its arrival on the European market."
The CHMP opinion is based on the results of two large-scale, prospective, randomized, double-blind, crossover clinical studies, PICTURE and PROMISE , conducted in more than 500 adult patients undergoing contrast-enhanced MRI and which aimed to compare the safety and efficacy of 0.05 mmol/kg Gadopiclenol compared to 0.1 mmol/kg Gadobutrol 3,4 . The PICTURE trial demonstrated comparable diagnostic efficacy at half the dose in CNS MRI, 5 the PROMISE trial in MRI of the head and neck, chest, breast, liver, pancreas, organs of the pelvis and the musculoskeletal system 6 .
Gadopiclenol offers two to three times greater relaxivity than available GBCAs 1 for use with any MR scanner, regardless of field strength. The macrocyclic structure of the contrast agent also gives it great stability 7 . The end result is adequate diagnostic efficacy at a dose of Vueway® lower than those approved for other macrocyclic GBCAs in clinical use, 2 while minimizing the risk of gadolinium retention in brain and body tissues, and possibly reducing the release of gadolinium to the environment 7 .
About Gadolinium-Based Contrast Agents
Gadolinium-based contrast agents (GBCA) are used in magnetic resonance imaging (MRI) procedures to help increase the visibility of certain tissues. Gadolinium is a rare earth metal with unique magnetic properties that make it useful for MR imaging.
About Gadopiclenol
Gadopiclenol, initially invented by Guerbet with subsequent contribution from Bracco IP, is a new gadolinium-based macrocyclic contrast agent (GBCA) with high relaxivity. The efficacy and safety of gadopiclenol have been evaluated in MRI of the Central Nervous System, head and neck, chest, abdomen, pelvis, and musculoskeletal system (For reference in the United States, see USPI approved).
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