Bracco's Vueway Expansion Targets Neonates, Bolsters Contrast Agent Portfolio
Event summary
- The European Medicines Agency's (EMA) CHMP issued a positive opinion on December 11, 2025, extending the approved indications of Bracco's Vueway® (gadopiclenol) to pediatric patients under 2 years of age.
- Vueway® is a macrocyclic gadolinium-based contrast agent (GBCA) already approved in 36 countries and used in MRI examinations.
- Clinical studies indicate Vueway® delivers comparable diagnostic efficacy at half the gadolinium dose of gadobutrol.
- Bracco and Guerbet have a collaboration for Gadopiclenol manufacturing and R&D, with both companies expected to manufacture the active ingredient and finished product after a transition period.
The big picture
This approval represents a strategic win for Bracco, expanding the addressable market for Vueway® and reinforcing its position as a leader in contrast agents. The lower dosage requirement, compared to competitors like gadobutrol, addresses growing concerns about gadolinium deposition and aligns with a trend toward minimizing patient exposure to contrast agents. The collaboration with Guerbet, while complex, positions Bracco to capitalize on the increased demand and potentially scale production efficiently.
What we're watching
- Adoption Rate
- The speed of adoption among pediatric radiologists will depend on clinical guidelines and perceived safety benefits, potentially impacting Vueway’s revenue growth in this new segment.
- Liability Risk
- Given ongoing concerns about gadolinium retention, Bracco will need to proactively manage any adverse event reporting and demonstrate continued safety in this vulnerable patient population.
- Competitive Response
- Other contrast agent manufacturers may accelerate their own development programs for pediatric formulations, intensifying competition and potentially eroding Bracco’s market share gains.
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