Bracco Announces FDA Approval of Gadopiclenol Injection, a New Macrocyclic High-Relaxivity Gadolinium-Based Contrast Agent which will be commercialized as VUEWAY™ (gadopiclenol) injection and VUEWAY – StreetInsider.com

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VUEWAY injection is highly stable and shows the highest relaxivity among gadolinium-based contrast agents available for clinical usei
VUEWAY injection is approved for use in adult and pediatric patients aged 2 years and older with magnetic resonance imaging (MRI) of the central nervous system (brain, spine, and surrounding tissues) and the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system)ii 
MONROE TOWNSHIP, N.J., Sept. 21, 2022 /PRNewswire/ — Bracco Diagnostics Inc., the United States (U.S.) subsidiary of Bracco Imaging S.p.A., an innovative world leader in diagnostic imaging, announced today 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 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 Please see Indications and Important Safety Information below, including Boxed Warning.
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“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 optionsv,” 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.”
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
“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.”
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.
“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. 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.”
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.
Visit VUEWAY.com for more information, including full Prescribing Information.
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 Details on Phase III clinical trials are available on www.ClinicalTrials.gov:
The Bracco Imaging and Guerbet Collaboration / The Guerbet and Bracco Imaging CollaborationBracco 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.
The strategic collaboration is expected to accelerate access to Gadopiclenol and deliver innovation, as well as better care to patients and caregivers alike.
VUEWAYTM (gadopiclenol) injection Important Safety Information
WARNING:  NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
See full prescribing information for complete boxed warning
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities.
Indications and UsageVUEWAY (gadopiclenol) injection is indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues), and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).
ContraindicationsHistory of hypersensitivity reactions to VUEWAY.
Warnings and Precautions
Adverse Reactions:In clinical trials, the most frequent adverse reactions that occurred in > 0.2% of patients who received VUEWAY included: injection site pain, headache, nausea, injection site warmth and coldness, dizziness, and localized swelling.
Adverse reactions that occurred with a frequency ≤ 0.2% in patients who received 0.05 mmol/kg BW VUEWAY included:  maculopapular rash, vomiting, worsened renal impairment, feeling hot, pyrexia, oral paresthesia, dysgeusia, diarrhea, pruritus, allergic dermatitis, erythema, injection site paresthesia, Cystatin C increase, and blood creatinine increase.
Use in Specific Populations
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for full Prescribing Information for VUEWAY, including BOXED WARNING on Nephrogenic Systemic Fibrosis.
Manufactured for Bracco Diagnostics Inc. by Liebel-Flarsheim Company LLC – Raleigh, NC, USA 27616.
VUEWAY is a trademark of Bracco Imaging S.p.A.
All other trademarks and registered trademarks are the property of their respective owners.
About Bracco ImagingBracco Imaging S.p.A. (“Bracco Imaging”), part of the Bracco Group, is an innovative world leader delivering end-to-end products and solutions through its comprehensive portfolio across diagnostic imaging modalities. Headquartered in Milan, Italy, Bracco Imaging’s purpose is to improve people’s lives by shaping the future of prevention and precision diagnostic imaging. 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. Bracco Imaging has approximately 3,600 employees and operates in more than 100 markets globally. Bracco Imaging has a well-skilled and innovative Research and Development (R&D) organization with an efficient process-oriented approach and track record in the diagnostic imaging industry. R&D activities are located in four centers based in Italy, Switzerland, the United Kingdom and the United States. Bracco Group global revenues were 1.4 billion Euros in 2020. To learn more about Bracco Imaging, visit www.braccoimaging.com.
Bracco Diagnostics Inc. Media Relations (USA)Kimberly GerweckSenior Manager, Marketing Communications[email protected]D: +1 609-524-2777
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.
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SOURCE Bracco Diagnostics Inc.
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