Vueway® (Gadopiclenol) Receives Positive CHMP Opinion

(Adnkronos) – The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of the macrocyclic, high-relaxivity Vueway® (Gadopiclenol) in adults and pediatric patients older than 2 years of age. MILAN, Oct. 13, 2023 /PRNewswire/ — Bracco Imaging S.p.A., an innovative world leader delivering end-to-end products and solutions through a comprehensive portfolio inclusive of precision diagnostic imaging modalities, today received notification that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Vueway® (Gadopiclenol) solution for injection for magnetic resonance imaging (MRI) for use in adult and pediatric patients aged 2 years and older with magnetic resonance imaging (MRI) of the CNS (brain, spine, and surrounding tissues) and several body organs (liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system). The European Commission is expected to issue its decision by the end of 2023. Vueway® (Gadopiclenol), is a new macrocyclic gadolinium-based contrast agent (GBCA), very stable and with the highest relaxivity among all the other GBCAs on the market today1, so that its approved dose is exactly half of that approved for other macrocyclic GBCAs for similar indications2. It was approved by the United States Food and Drug Administration (US FDA) in September 2022. "The high relaxivity of Vueway® has shown to allow an improvement of its risk-benefit profile by reducing exposure without compromising imaging performance," said 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 for the environment. We eagerly anticipate its arrival to the European market." The CHMP opinion is based on the results from two prospective, large-scale, randomized, double-blind, crossover clinical studies, PICTURE and PROMISE, conducted in more than 500 adult patients undergoing contrast-enhanced MRI and aimed at comparing the safety and efficacy of 0.05 mmol/kg Gadopiclenol compared with 0.1 mmol/kg Gadobutrol3,4. The PICTURE trial demonstrated comparable diagnostic efficacy at half dose in MRI of the central nervous system5, the PROMISE trial in MRI of the head and neck, chest, breast, liver, pancreas, pelvis organs, and the musculoskeletal system6. Gadopiclenol offers a two-to-three-fold higher relaxivity than available GBCAs1 for use with any MRI scanner, regardless of field strength. The contrast agent's macrocyclic structure also confers high stability7. The end result is adequate diagnostic efficacy at a Vueway® dose which is lower than those approved for other macrocyclic GBCAs in clinical use2, while minimizing the risk of gadolinium retention in brain and body tissues, and possibly reducing release of gadolinium in the environment7. About gadolinium-based contrast agentsGadolinium-based contrast agents (GBCAs) are used in magnetic resonance imaging (MRI) procedures to help enhance the visibility of certain tissues. Gadolinium is a rare earth metal that has unique magnetic properties that make it useful for MRI imaging. About gadopiclenolGadopiclenol, initially invented by Guerbet with subsequent contribution of Bracco IP, is a new macrocyclic gadolinium-based 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, thorax, abdomen, pelvis, and musculoskeletal system (For US reference, refer to the approved USPI). Details on Phase III clinical trials are available on www.ClinicalTrials.gov: About the PICTURE trial1The PICTURE trial included 256 patients with known or highly suspected CNS lesion(s). All primary and secondary endpoints of the study were achieved. All blinded readers' evaluations indicated the superiority of the combined unenhanced/contrast-enhanced MRI with 0.05 mmol/kg gadopiclenol over unenhanced MRI alone for all lesion visualisation criteria (p