FDA Approves Bracco Diagnostic Inc.'s ProHance® (Gadoteridol) Injection, 279.3 mg/mL, for Pediatric Patients Younger than Two Years
MONROE TOWNSHIP, N.J., Dec. 23, 2020 /PRNewswire/ --Bracco Diagnostics Inc. the U.S subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today 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.
Indications and Usage for ProHance® (Gadoteridol) Injection, 279.3 mg/mL and
CENTRAL NERVOUS SYSTEM
EXTRACRANIAL/EXTRASPINAL HEAD AND NECK
IMPORTANT SAFETY INFORMATION:
WARNINGS AND PRECAUTIONS
USE IN SPECIFIC POPULATIONS
Please see full Prescribing Information and Patient Medication Guide for additional important safety information for/regarding ProHance® (Gadoteridol) Injection, 279.3 mg/mL and ProHance® Multipack™ (Gadoteridol) Injection, 279.3 mg/mL at https://imaging.bracco.com/sites/braccoimaging.com/files/technica_sheet_pdf/us-ProHance-PI-DEC2020-4718378.pdf
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
ProHance is manufactured for Bracco Diagnostics Inc. by BIPSO GmbH – 78224 Singen (Germany).
ProHance is a registered trademark of Bracco Diagnostics Inc.
ProHance Multipack is a trademark of Bracco Diagnostics Inc.
For additional information about Bracco's products, and for full prescribing information, please visit http://imaging.bracco.com/us-en.
About Bracco Imaging S.p.A.
Bracco Imaging offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), magnetic resonance imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. The Company operates in over 100 markets worldwide, either directly or indirectly, through subsidiaries, joint ventures, licenses and distribution partnership agreements. Bracco Imaging has a strong presence in key geographies: North America, China, Europe, Japan, Brazil, Mexico and South Korea.
Bracco Imaging's manufacturing plants operate in full compliance with the best practices and sustainable eco-friendly production processes. Manufacturing sites are based in Italy, Switzerland, Germany, Canada, China, Japan, and the USA.
Bracco Imaging has a well-skilled and innovative Research and Development (R&D) organization with an efficient process-oriented approach and track record in the diagnostic imaging industry. R&D activities are located in three centers based in Italy, Switzerland and the USA. To learn more about Bracco Imaging, visit www.braccoimaging.com.
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SOURCE Bracco Diagnostics Inc.