Friday, October 13, 2023
Bracco Imaging SpA, a globally renowned leader in innovative solutions for precision diagnostic imaging, has received encouraging news. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a favorable recommendation for the approval of Vueway® (Gadopiclenol) injectable solution for magnetic resonance imaging (MRI) in both adult and pediatric patients starting from the age of 2. This approval encompasses MRI examinations of the central nervous system (CNS), including the brain, spine, and adjacent tissues, as well as various body organs such as the liver, kidney, pancreas, breast, lung, prostate, and the musculoskeletal system.
The European Commission is expected to make its final decision by the conclusion of 2023. This positive opinion from CHMP is grounded in the outcomes of two extensive clinical studies, PICTURE and PROMISE. These studies were prospective, randomized, double-blind, crossover trials that involved over 500 adult patients undergoing contrast-enhanced MRI. Their purpose was to evaluate the safety and efficacy of Gadopiclenol at a dosage of 0.05 mmol/kg compared to Gadobutrol at a dosage of 0.1 mmol/kg.
The PICTURE trial demonstrated that Gadopiclenol, at half the dosage, delivers diagnostic efficacy that is on par with that of Gadobutrol for CNS MRI. The PROMISE trial confirmed its effectiveness for MRI examinations of the head and neck, chest, breast, liver, pancreas, pelvis, and musculoskeletal system. Gadopiclenol possesses two to three times greater relaxivity compared to other available gadolinium-based contrast agents (GBCAs) and is compatible with MR scanners of various field strengths. Its macrocyclic structure ensures exceptional stability.
As a result, Vueway® can provide adequate diagnostic efficacy at a lower dose than other macrocyclic GBCAs in clinical use. This not only reduces the risk of gadolinium retention in brain and body tissues but also has the potential to decrease the release of gadolinium into the environment. This development represents a significant milestone in the realm of diagnostic imaging.