The European Commission has granted market authorisation to Italy-based Bracco Imaging’s Vueway (gadopiclenol), a gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging (MRI).
Vueway is delivered via intravenous injection to increase the contrast of structures or fluids within the body in contrast-enhanced MRI (CE-MRI) scans. The agent has half the dose of gadolinium to that of standard agents.
The positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), along with the recommendation sent by EMA to the EC, is based on positive results from two crossover clinical studies - PICTURE, and PROMISE.
The PICTURE study evaluated the safety and efficacy of Vueway compared to Gadavist (gadobutrol), a GBCA marketed by Bayer AG, in 256 adult patients with suspected CNS disease. Vueway provided greater enhancement of contrast between the CNS lesions and the surrounding brain and spine structures at half the dosage of Gadavist, and similar quality of visualisation of brain and spine disease.
The multi-centre, randomised, double-blind Phase III PROMISE study (NCT03986138) enrolled 304 patients in a comparison of 0.05mmol/kg Vueway and 0.1mmol/kg Gadavist during various CE-MRI exams. The results of the study showed Vueway to be non-inferior to Gadavist.
“Vueway will not only lower the rate of inaccurate or inconclusive results of MRI procedures but may also contribute to improve treatment plans tailored to individual patient needs," said Bracco Imaging CEO, Fulvio Renoldi.
The Vueway injection is the result of a partnership between Bracco and Guerbet for the research, development, and manufacturing of the product, signed in December 2021. Under the agreement, Guerbet and Bracco will independently commercialise the product, under different brand names, with Guerbet’s agent called Elucirem.
The contrast agent scored approval from the US Food and Drug Administration (FDA) in 2022 for the use with MRI for adults and children over the age of two, in the central nervous system (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system).
According to a report by GlobalData, the contrast agents market share in the US will reach $18.7bn by 2030. Bracco made up 31.1% of the global contrast agents market share in 2021.
