News | Contrast Media | September 22, 2022

Bracco Diagnostics Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Gadopiclenol Injection, a new, highly stable macrocyclic gadolinium-based contrast agent (GBCA). The introduction of VUEWAY injection is the result of a strategic, global collaboration between Bracco and Guerbet in both research, development, and manufacturing of the product signed in December 2021.

Bracco Diagnostics Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Gadopiclenol Injection, a new, highly stable macrocyclic gadolinium-based contrast agent (GBCA), in partnership with Guerbet.. 

Photo Credit: Getty Images.


Editor’s note: On September 21, 2022, both Guerbet and Bracco Diagnostics released news detailing the FDA approval of a new gadolinium-based contrast agent. In consideration of the surge of GBCA use the imaging industry has experienced, as a result of COVID lockdowns in China and related contrast agent shortages that led to conservation strategies, ITN is providing information from both companies involved in this important partnership update. Access to the first article, and an extensive feature about the shortage, is provided in Related Content below.

September 22, 2022 — Bracco Diagnostics Inc., the United States subsidiary of Bracco Imaging S.p.A., announced that the U.S. Food and Drug Administration (FDA) has approved Gadopiclenol Injection, a new, highly stable macrocyclic gadolinium-based contrast agent (GBCA), which shows the highest relaxivity compared to all the other GBCAs available today in the United States. (i,ii) 

"The approval of Gadopiclenol Injection follows Priority Review, which is granted by the FDA for products that are considered significant improvements in safety or effectiveness when compared to standard options (v)," said Alberto Spinazzi, MD, Chief Medical and Regulatory Officer at Bracco. "This is because Gadopiclenol Injection, to be marketed by Bracco as VUEWAY injection, is a first-of-its-kind MRI agent that delivers the highest relaxivity and highest kinetic stability of all GBCAs on the market today. (i) Highly stable, clinical studies showed that VUEWAY injection provides effective contrast enhancement and diagnostic efficacy at half the approved dose of Gadobutrol injection and Gadobenate dimeglumine injection, another high-relaxivity agent. (iii,iv,vi) The positive benefit-risk profile of VUEWAY injection has been demonstrated across a large number of indications, including some for which GBCAs had not previously been approved in the United States."

Impact on Imaging Community

The introduction of VUEWAY injection is the result of a strategic, global collaboration between Bracco and Guerbet in both research, development, and manufacturing of the product signed in December 2021.

The announcement paves the way for a new marketing paradigm that is designed to ensure the broadest possible access to patients and their healthcare professionals in need of imaging agents. Gadopiclenol will be independently commercialized by both Bracco Diagnostics (as VUEWAY) and Guerbet, industry competitors that each played a role in its development, according to the Bracco Imaging announcement. It further reported that the commercialization of Gadopiclenol by both companies will expand access to this first-of-its kind contrast agent by one and a half times, reflecting Bracco’s 30% share of the contrast agent market.    

"During a year where we will celebrate our 95th anniversary, we are excited to deliver this unique MRI agent to the healthcare community and the patients they serve, a testament to our legacy of innovation," said Fulvio Renoldi Bracco, Vice-Chairman & CEO of Bracco Imaging. "The approval of VUEWAY injection is representative of the commitment of our workforce comprised of more than 300 scientists and engineers who continuously strive to improve the diagnostic performance of medical imaging and patient outcomes."

About Gadopiclenol Injection

Gadopiclenol Injection will be commercialized by Bracco as VUEWAY (gadopiclenol) injection and VUEWAY (gadopiclenol) Pharmacy Bulk Package. VUEWAY injection is approved for use with MRI in adults and pediatric patients aged 2 years and older to detect and visualize lesions in the central nervous system (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system)ii The approved dose is 0.05 mmol/kg, which was shown to improve the detection and visualization of lesions over unenhanced MRI alone, and to provide similar diagnostic efficacy compared with 0.1 mmol/kg of the lower-relaxivity Gadobutrol injection in the approved indications.iii,iv 

The pivotal Phase III studies supporting approval of VUEWAY injection were designed as crossover studies, within-patient comparisons of MRI of the CNS or MRI of the body with 0.05 mmol/kg VUEWAY injection or unenhanced MRI alone, and 0.05 mmol/kg Gadopiclenol with 0.1 mmol/kg Gadobutrol in adult patients.iii,iv Even at half dose, MRI with Gadopiclenol was shown to be non-inferior to MRI with the full dose of Gadobutrol. In MRI of the CNS, the quality of visualization obtained with a half-dose of Gadopiclenol was preferred to that of Gadobutrol by all the blinded readers.

No major safety signals were reported during the development of VUEWAY in either adult or pediatric patients, and the adverse events reported during the two Phase III studies were similar for both of the products administered.ii

Through this global collaboration, Guerbet and Bracco will commercialize the product independently under different brand names. A Centralized Application for Marketing Authorization to the European Medicines Agency (EMA) for Gadopiclenol Injection was submitted earlier this year.

Gadopiclenol, initially invented by Guerbet with subsequent contribution of Bracco IP, is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity.i 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 (refer to the approved USPI for full information).ii 

Collaboration

Bracco Imaging and Guerbet in December 2021 entered a worldwide collaboration on Gadopiclenol manufacturing and research and development activities. Gadopiclenol will be commercialized independently under separate brands. Both Guerbet and Bracco Imaging each own valuable intellectual property on Gadopiclenol. Furthermore, after an agreed transition period when Guerbet manufactures Gadopiclenol for both Guerbet and Bracco, both companies will manufacture the Gadopiclenol active ingredient and finished product.

"This strategic collaboration will expand access to this important new contrast agent which has the potential to help improve diagnoses and ultimately improve patient care," said Cosimo De Pinto, Senior Vice President of Sales and Marketing at Bracco Diagnostics Inc. "By exploring a flexible application of our intellectual property rights, we've seen that joining forces has led to meaningful innovation at a faster pace,” he noted, adding, “One of the greatest barriers to health equity and access is overly strict adherence to traditional approaches to knowledge and information sharing. The more we collaborate, the more we unencumber healthcare delivery at moments when it matters most."

Bracco Imaging S.p.A. ("Bracco Imaging"), headquartered in Milan, Italy, is part of the Bracco Group. VUEWAY is a trademark of Bracco Imaging S.p.A. The company delivers end-to-end products and solutions through its comprehensive portfolio across diagnostic imaging modalities. The Bracco Imaging portfolio includes products and solutions for all key diagnostic imaging modalities: X-ray imaging, magnetic resonance imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents.

For more information: https://www.braccoimaging.com/global

References:

i   Robic C, Port M, Rousseaux O, et al. Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate With High T1 Relaxivity. Invest Radiol 2019; 54: 475-484.
ii   Vueway™ (gadopiclenol) injection Full Prescribing Information. Monroe Twp., NJ: Bracco Diagnostics Inc.; September 2022.
iii Clinical Study Report of Study GDX-44-011. Data on file.
iv Clinical Study Report of Study GDX-44-010. Data on file.
v US FDA. Priority Review. Available at: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review. Accessed August 22, 2022.
vi Bendszus M, Roberts D, Kolumban B, et al. Dose Finding Study of Gadopiclenol, a New Macrocyclic Contrast Agent, in MRI of Central Nervous System. Invest Radiol. 2020 Mar;55(3):129-137.

Related Content:

https://www.itnonline.com/content/guerbet-announces-fda-approval-elucirem-gadopiclenol-use-contrast-enhanced-mri

https://www.itnonline.com/article/contrast-media-supply-shortage-how-and-what-now

https://www.itnonline.com/content/fda-grants-import-discretion-bracco%E2%80%99s-iodinated-contrast-medium-iomeron-iomeprol-injection


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