Bracco Diagnostics Inc. the U.S subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, has announced that the U.S. Food and Drug Administration (FDA) has approved ProHance® (Gadoteridol) Injection, 279.3 mg/mL for intravenous use with magnetic resonance imaging (MRI) in pediatric patients under two years old, including term neonates, to visualize areas with disrupted blood brain barrier and/or abnormal vascularity throughout the brain, spine and associated tissues. ProHance was previously approved for this use in patient populations over the age of two.
"Term neonates, our youngest patients, are special and this approval is an important milestone in providing them with the specialized care they need," said Vittorio Puppo, President and CEO of Bracco Diagnostics Inc. "Bracco is dedicated to providing healthcare providers with safe and effective contrast media to help them meet the challenges presented by this unique patient population, and ultimately improve diagnosis. The inclusion of term neonates to the label reinforces the safety of ProHance, the fastest growing GBCA on the market today."
The approval of the extended label was based on a study of pediatric patients undergoing magnetic resonance imaging (MRI) of the central nervous system (CNS) showing that ProHance at the standard dose (0.10 mmol/kg) was effective in improving the three co-primary visualization endpoints: lesion border delineation, visualization of lesion internal morphology, and lesion contrast enhancement. Pharmacokinetic (PK) simulations and safety evaluations indicate that these data in pediatric patients under two years of age were similar to those of adults.
The retrospective study enrolled 125 pediatric patients with ages ranging from term neonates to 24 months old; 17 were less than 1 month of age, 40 were between 1 month and 6 months of age, 29 were between 6 months and 12 months of age, and 39 were between 12 months and 24 months of age. Three independent, blinded radiologists evaluated the paired pre- and post-contrast MRI image sets and all three reported improvement in the paired image sets for each of the three co-primary endpoints.
ProHance® (Gadoteridol) Injection, 279.3 mg/mL is indicated for use in MRI in adults and pediatric patients including term neonates to visualize lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. ProHance (Gadoteridol) Injection, 279.3 mg/mL is also indicated for use in MRI in adults to visualize lesions in the head and neck.Back To Top
FDA Approves Bracco's ProHance Injection for Pediatric Patients Under Age Two. Appl Radiol.