Health Canada Approves Bracco's VUEWAY® for Reduced Dose MRI Contrast Imaging

Bracco Imaging has received approval from Health Canada for its VUEWAY® injection (gadopiclenol), a novel macrocyclic gadolinium-based contrast agent for use in contrast-enhanced MRI (CE-MRI). This approval marks a significant advancement in minimizing gadolinium exposure without compromising diagnostic quality.

VUEWAY® distinguishes itself as a macrocyclic agent with high kinetic stability and the highest longitudinal relaxivity among macrocyclic gadolinium-based contrast agents (GBCAs) available in key global markets. Clinical studies have shown that VUEWAY® can achieve effective contrast enhancement at a dose of 0.05 mmol/kg, half the conventional 0.1 mmol/kg dose for other GBCAs. This reduced dosage aligns with clinical recommendations from radiology societies to use the lowest effective dose possible for CE-MRI.

"Reducing gadolinium exposure is not only a clinical priority but increasingly an environmental one," said Dr. Kate Hanneman, Radiologist & Deputy Lead for Sustainability at the Joint Department of Medical Imaging, University of Toronto. "High-relaxivity gadolinium-based contrast agents that deliver diagnostic confidence at half the standard dose represent an important advance for Canadian patients, supporting both patient safety and environmental stewardship."

VUEWAY® is approved for use in adults and children aged 2 years and older to detect and visualize lesions with blood-brain-barrier disruption and/or abnormal vascularity in the central nervous system, head and neck, thorax, abdomen, pelvis, and musculoskeletal system.

The Health Canada approval follows prior approvals in the United States (2022) and the European Union (2023), with the agent now approved in 37 countries and administered to over 4 million patients worldwide. The Canadian approval enhances Bracco's standing in magnetic resonance imaging (MRI) by supporting radiologists’ objectives to reduce gadolinium agent exposure in frequent CE-MRI procedures for both children and adults.

According to Mr. Patrice Plourde, Sr. Director of Sales & Marketing at Bracco Imaging Canada, "This approval is a pivotal milestone aligning with our commitment to the ALARA (as low as reasonably achievable) principle, focusing on patient safety while minimizing environmental impact. Bracco Imaging remains committed to elevating diagnostic standards across Canada."

Bracco and Guerbet have a strategic collaboration on gadopiclenol, focusing on shared research and development responsibilities while each commercializes the product independently.

Gadopiclenol was initially developed by Guerbet, with Bracco contributing to its intellectual property. It has now established a presence in major markets and continues to support advancements in diagnostic imaging.