Bracco Imaging gains regulatory momentum as CHMP supports gadopiclenol for patients under two

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Vueway gadopiclenol be approved for use in pediatric patients from birth to under two years of age, marking a meaningful regulatory expansion for Bracco Imaging S.p.A. in Europe. If formally endorsed by the European Commission, the decision would extend the product’s existing authorization beyond adults and children over two, positioning Vueway gadopiclenol as one of the few macrocyclic gadolinium-based contrast agents cleared for routine MRI use in neonates and very young infants.

Why the CHMP opinion on Vueway gadopiclenol matters for pediatric imaging safety in Europe

Pediatric contrast-enhanced magnetic resonance imaging has long occupied a cautious regulatory space, particularly for neonates and infants whose developing organs and immature blood–brain barriers raise heightened safety considerations. The CHMP opinion signals that European regulators are increasingly willing to differentiate between gadolinium-based contrast agents on the basis of molecular stability, dose efficiency, and long-term risk mitigation rather than treating the class as homogeneous.

Vueway gadopiclenol is a macrocyclic agent, a structural characteristic associated with greater kinetic and thermodynamic stability compared with older linear agents. This matters because regulatory scrutiny over gadolinium retention has intensified over the past decade, especially in populations with immature renal clearance or long life expectancy ahead of them. By backing use from birth, the CHMP is effectively stating that the benefit-risk balance is acceptable even in the most vulnerable patient cohorts when exposure is minimized and diagnostic yield preserved.

How lower gadolinium dose efficiency reshapes the benefit-risk equation in infants

One of the most consequential aspects of Vueway gadopiclenol is its high longitudinal relaxivity, which allows radiologists to achieve comparable diagnostic contrast at roughly half the gadolinium dose of gadobutrol, one of the most widely used macrocyclic agents globally. For neonates and infants, dose efficiency is not a marginal technical improvement but a central clinical consideration.

Reducing total gadolinium exposure addresses two persistent concerns simultaneously. First, it lowers systemic gadolinium burden in patients whose renal function is still maturing. Second, it mitigates uncertainty around long-term tissue retention, an issue that remains under active scientific investigation. While definitive causal links between retained gadolinium and adverse outcomes have not been established, regulators have consistently favored agents and protocols that reduce unnecessary exposure, particularly when alternative options deliver equivalent diagnostic information.

The CHMP’s positive opinion reflects growing confidence that lower-dose, high-relaxivity agents can offer a pragmatic compromise between diagnostic necessity and precautionary safety principles in pediatric radiology.

What this decision reveals about evolving EMA regulatory priorities for contrast agents

The European Medicines Agency has, over recent years, moved toward a more granular regulatory framework for imaging agents, balancing pharmacovigilance with clinical practicality. Rather than blanket restrictions, regulators are increasingly relying on comparative pharmacology, real-world usage data, and targeted clinical trials to refine indications.

In this context, the Vueway gadopiclenol decision underscores a shift toward indication-specific and population-specific approvals. The CHMP relied on data from the GDX-44-015 clinical program, which evaluated safety and diagnostic performance in very young patients, including neonates. The endorsement suggests that the EMA is open to expanding pediatric indications when sponsors can demonstrate both stability advantages and dose-reduction benefits, even within a class of agents subject to long-standing caution.

This approach aligns with broader European regulatory goals of supporting precision medicine and tailored diagnostics without compromising safety oversight.

How Bracco Imaging S.p.A. strengthens its competitive position in MRI contrast media

For Bracco Imaging S.p.A., the CHMP opinion is strategically significant beyond the immediate pediatric indication. Vueway gadopiclenol has already been approved in multiple global markets and in the European Union for adults and children aged two and above. Extending use to patients from birth enhances the product’s clinical versatility and strengthens Bracco Imaging S.p.A.’s positioning against competitors offering gadolinium-based agents with more limited pediatric labeling.

In procurement-driven healthcare systems, especially across Europe, broader label indications can translate directly into formulary preference. Hospitals and imaging networks often favor contrast agents that can be standardized across age groups to simplify protocols, reduce inventory complexity, and ensure consistency of care. A single agent that can be used safely from neonatal imaging through adulthood carries operational appeal that goes well beyond its pharmacological profile.

What pediatric radiologists and hospitals are likely to change if approval is finalized

If the European Commission ratifies the CHMP recommendation, pediatric radiology departments may begin reassessing contrast protocols for infants and toddlers. While adoption will vary by country and institution, the availability of a lower-dose macrocyclic agent with an explicit from-birth indication could influence guideline updates and institutional policies.

In practice, this does not mean that contrast-enhanced MRI will suddenly become routine in neonates. Clinical justification will remain paramount, and non-contrast imaging will continue to be preferred whenever feasible. However, when contrast is clinically necessary, the decision broadens the toolkit available to clinicians, potentially reducing reliance on off-label use or more conservative imaging alternatives that compromise diagnostic clarity.

Why gadolinium retention concerns remain relevant despite regulatory confidence

Despite the positive regulatory signal, it is important to recognize that the long-term implications of gadolinium retention are still an active area of research. The CHMP opinion does not suggest that these concerns have disappeared, but rather that they can be responsibly managed through agent selection, dose optimization, and evidence-based use.

Macrocyclic agents like Vueway gadopiclenol are generally associated with lower levels of gadolinium retention than linear agents, and lower dosing further reduces cumulative exposure. For regulators, clinicians, and manufacturers alike, the current priority is risk minimization rather than absolute risk elimination, acknowledging both the diagnostic necessity of contrast-enhanced MRI and the ethical imperative to protect pediatric patients.

How this decision could influence future pediatric imaging approvals

The Vueway gadopiclenol opinion may serve as a reference point for future pediatric submissions in diagnostic imaging. Sponsors developing next-generation contrast agents or imaging adjuncts will likely view this decision as confirmation that robust pediatric data, coupled with clear dose-reduction advantages, can unlock broader indications even in conservative regulatory environments.

For the imaging industry, the message is clear: innovation that demonstrably reduces patient burden while maintaining diagnostic performance is more likely to receive regulatory support, particularly in sensitive populations such as neonates and infants.

Key takeaways on what the CHMP opinion means for Bracco Imaging S.p.A. and pediatric MRI practice

• The CHMP opinion supports extending Vueway gadopiclenol use to pediatric patients from birth, pending European Commission approval.

• Lower gadolinium dose efficiency is central to the favorable benefit-risk assessment in neonates and infants.

• The decision reflects evolving European regulatory priorities toward differentiated, population-specific approvals for contrast agents.

• Bracco Imaging S.p.A. strengthens its competitive position with a broader pediatric label that appeals to hospital procurement and protocol standardization.

• Pediatric radiology practices gain an additional option that balances diagnostic clarity with exposure minimization.

• Gadolinium retention concerns persist, but regulators increasingly emphasize risk mitigation through agent selection and dosing strategies.

• The outcome may influence how future pediatric imaging agents are developed, studied, and submitted for approval.