FDA Extends VUEWAY Approval for Use in Neonates and Infants

The U.S. Food and Drug Administration (FDA) has expanded the approval of VUEWAY® (gadopiclenol) solution for injection, enabling its use in neonates and infants. This decision marks a significant advancement in providing safer diagnostic imaging options for the youngest patients.

VUEWAY® is a macrocyclic gadolinium-based contrast agent (GBCA) that enhances MRI results with half the gadolinium dose required by other approved macrocyclic GBCAs in the United States. This advancement potentially reduces the cumulative gadolinium exposure without compromising the diagnostic image quality, which is particularly crucial for neonates and infants with developing tissues.

Clinical recommendations from radiology societies stress the importance of using the lowest effective GBCA dose, aligning with this latest FDA approval. Teresa Chapman, MD, MA, FACR, from the University of Wisconsin School of Medicine, emphasized the importance of minimizing cumulative gadolinium exposure while maintaining high diagnostic quality in pediatric imaging.

VUEWAY®’s unique formulation contains the highest longitudinal relaxivity (r1) values among GBCAs, ensuring optimal diagnostic performance. Extensive studies revealed that VUEWAY® achieves comparable efficacy at half the gadolinium dose of widely used alternatives, such as gadobutrol.

The newly approved application of VUEWAY® for neonates and infants aligns with ongoing efforts in radiology to improve safety, especially for patients undergoing multiple MRIs. As highlighted by Jeffrey H. Miller, MD, at Phoenix Children's Hospital, using a contrast agent that provides effective imaging at a lower dose represents meaningful progress in pediatric care.

Since its initial FDA approval in September 2022, over 3.5 million VUEWAY® doses have been administered across the U.S., indicating widespread clinical acceptance. The latest expansion underscores the commitment to safe contrast-enhanced MRI for patients from birth, as stressed by Gary Ray, Associate Director of MR Contrast at Bracco Americas.

The recent FDA approval is backed by data from study GDX-44-015, evaluating the safety and efficacy of VUEWAY® in pediatric populations. Initially approved for patients aged two years and older, VUEWAY®’s indication now includes infants and neonates. This expansion follows similar EU approvals, further solidifying its role in pediatric radiology.

For comprehensive safety details, the prescribing information for VUEWAY® injection includes warnings on nephrogenic systemic fibrosis and other considerations pertinent to its use. Clinicians are advised to adhere to recommended dosing guidelines to maximize safety and diagnostic capability.

Further information and clinical guidelines are available at Bracco’s official website, supporting healthcare professionals in delivering optimal patient care.