The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of the highly relaxing macrocyclic Vueway® (Gadopiclenol) in adults and pediatric patients over 2 years of age

MILAN, October 13, 2023/PRNewswire/ -- Bracco Imaging S.p.A., 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 marketed1, so its approved dose is exactly half of the approved for other macrocyclic GBCAs for similar indications2. 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 Gadobutrol3,4. The PICTURE trial demonstrated comparable diagnostic efficacy at half the dose in central nervous system MRI,5 the PROMISE trial in MRI of the head and neck, chest, breast, liver, pancreas, the pelvis and the musculoskeletal system6.

Gadopiclenol offers two to three times greater relaxivity than available GBCAs1 for use with any MR scanner, regardless of field strength. The macrocyclic structure of the contrast agent also gives it great stability7. The end result is adequate diagnostic efficacy at a dose of Vueway® 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 to the environment7.

About Gadolinium-Based Contrast AgentsGadolinium-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 GadopiclenolGadopiclenol, 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).

Details about Phase III clinical trials available at www.ClinicalTrials.gov:

About the PICTURE Trial1The PICTURE trial enrolled 256 patients with known or highly suspected CNS lesions. All primary and secondary endpoints of the study were met. All evaluations by blinded readers indicated the superiority of combined non-contrast/contrast-enhanced MRI with 0.05 mmol/kg gadopiclenol over non-contrast MRI alone in all lesion visualization criteria (p<0.0001). For all three blinded readers, non-inferiority of 0.05 mmol/kg gadopiclenol versus 0.1 mmol/kg gadobutrol (Gadavist) was demonstrated in all lesion visualization criteria (p<0.0001). Results also indicated a higher percent contrast enhancement for all readers (p<0.0001), a higher contrast-to-noise ratio for two of the three readers (p<0.01), and a higher lesion-to-background contrast ratio. superior with gadopiclenol for all readers (p<0.0001). In correlation with the greater contrast enhancement, the diagnostic quality of the images obtained with 0.05 mmol/kg of gadopiclenol was mostly preferred to that provided by 0.1 mmol/kg of gadobutrol by the three blinded readers (p<0.001) .

About the PROMISE2 Trial The PROMISE trial enrolled 273 adult patients suspected of having an enhancement abnormality in one of three different body regions (head/neck, chest/thorax/abdomen/pelvis, or musculoskeletal). Externally blinded readers with experience in the respective body regions assessed border delineation, internal morphology, and visual contrast enhancement. All primary and secondary endpoints of the study were met. For all blinded readers, gadopiclenol 0.05 mmol/kg was noninferior to gadobutrol 0.1 mmol/kg in all viewing parameters and in all readers (p<0.001), and was superior to imaging without enhancement (p<0.001). Two of the three readers obtained a greater percentage of enhancement with gadopiclenol (P<0.001). The lesion/background ratio did not differ. For the majority of participants (75%-83%), readers did not express a preference between the 0.05 mmol/kg gadopiclenol images and the 0.1 mmol/kg gadobutrol images.

About Bracco ImagingBracco Imaging S.p.A. ("Bracco Imaging"), part of the Bracco Group, is a global innovative leader offering comprehensive products and solutions through its broad portfolio of diagnostic imaging modalities. Based in Milan, Italy, Bracco Imaging's goal is to improve people's lives by shaping the future of prevention and precision diagnostic imaging. Bracco Imaging's portfolio includes products and solutions for all key diagnostic imaging modalities: X-ray, Magnetic Resonance (MRI), Contrast Ultrasound (CEUS) and Nuclear Medicine using radioactive tracers and novel PET imaging agents. Bracco Imaging has approximately 3,700 employees and operates in more than 100 markets around the world. Bracco Imaging has a well-skilled and innovative Research and Development (R&D) organization with an efficient process-oriented approach and a track record in the diagnostic imaging sector. R&D activities are carried out in four centers located in Italy, Switzerland, the United Kingdom and the United States. The Bracco Group's global revenues amounted to €1.7 billion in 2020. For more information about Bracco Imaging, visit www.bracco.com.

THE COLLABORATION BETWEEN BRACCO IMAGING AND GUERBETBracco Imaging and Guerbet began a global collaboration in December 2021 for the manufacturing of Gadopiclenol and research and development activities. Gadopiclenol will be marketed independently under separate brand names. Both Guerbet and Bracco Imaging own valuable intellectual property on Gadopiclenol. Furthermore, following an agreed transition period in which Guerbet manufactures Gadopiclenol for both Guerbet and Bracco, both companies will manufacture the active ingredient and finished product of Gadopiclenol.

The strategic collaboration is expected to accelerate access to Gadopiclenol and deliver innovation as well as improved care to patients and caregivers alike.

Bracco ImagingMicaela ColamasiResponsible for RR.PP.Micaela.Colamasi@bracco.com 39 348 2314362

1 Robic C, Port M, Rousseaux O, et al. Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium ChelateWith High T1 Relaxivity. Invest Radiol 2019; 54: 475-484.

2 https://www.hpra.ie/img/uploaded/swedocuments/Licence_PA0686-003002_15052023150215.pdf https://www.medicines.org.uk/emc/product/14787/smpc https://www.medicines.org .uk/emc/product/2876/smpc https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20211118000026 https://www.medicines.org.uk/emc/product/349/smpc

3 https://clinicaltrials.gov/study/NCT03986138?intr=gadopiclenol

4 https://clinicaltrials.gov/study/NCT03996447?intr=gadopiclenol

5 Loevner LA, Kolumban B, Hutóczki G, et al. Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System: The PICTURE Randomized Clinical Trial. Invest Radiol. 2023; 58:307-313

6 Kuhl C, Csőszi T, Piskorski W, Miszalski T, Lee JM, Otto PM. Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI. Radiology 2023; 308: e222612

7 Runge VM and Heverhagen, JT. Advocating the Development of Next-Generation High-Relaxivity Gadolinium Chelates for Clinical Magnetic Resonance. Invest Radiol. 2018 Jul;53(7):381-389

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