Bracco wins Health Canada approval for Vueway

Bracco Imaging has received Health Canada approval for Vueway injection, a macrocyclic gadolinium-based contrast agent for use in contrast-enhanced MRI. Health Canada approved the agent on April 10, according to the company.

The agent is indicated for adults and children 2 years and older to detect and visualize lesions with disruption of the blood-brain barrier or abnormal vascularity. The indication covers the central nervous system, including the brain, spine, and surrounding tissues, as well as body imaging.

The approved body indications include the head and neck, thorax, abdomen, pelvis, and musculoskeletal system, according to Bracco.

The recommended dose in Canada is 0.1 mL/kg body weight, equivalent to 0.05 mmol/kg, administered intravenously as a bolus. The product monograph states that safety and effectiveness have not been assessed in pediatric patients younger than 2 years.

Bracco said Vueway has the highest longitudinal relaxivity values among macrocyclic gadolinium-based contrast agents approved in major global markets. The company also said clinical studies showed effective contrast enhancement at half the 0.1 mmol/kg dose used with other GBCAs.

The Canada approval follows regulatory clearances in the U.S. in 2022 and the European Union in 2023. Bracco said the agent is now approved in 37 countries, with more than 4M patient doses administered worldwide.