Most newly approved biologics studied in peds population

Most newly approved biologics studied in peds population
The majority of biologics approved since 1997 include pediatric information in their labeling and have been studied in pediatric trials, according to a review published online Jan. 14 in Pediatrics.

(HealthDay)—The majority of biologics approved since 1997 include pediatric information in their labeling and have been studied in pediatric trials, according to a review published online Jan. 14 in Pediatrics.

Marilyn J. Field, Ph.D., from the Institute of Medicine in Washington D.C., and colleagues reviewed from 96 biologics and 55 vaccines licensed by the U.S. between 1997 and 2010, which were still marketed as of 2010, for information on approved pediatric uses, pediatric studies, or pediatric based on analyses of adverse events. Registered pediatric studies of these biologics were identified through ClinicalTrials.gov.

The researchers found that about 60 percent of the biologics had labeling demonstrating approved pediatric study information or pediatric use or both. At least one registered pediatric trial was completed, underway, or planned for about 85 percent of the biologics. In total, about 90 percent of biologics had one or a combination of the following characteristics: were labeled for pediatric use, had pediatric information in the label, or had a registered pediatric study; as did 95 percent of analyzed vaccines.

"Overall, this analysis indicates substantial investigation of pediatric uses of biologics by government, industry, and non-industry sponsors of research," the authors write. "Most of the products with neither pediatric labeling nor registered pediatric studies are approved for indications that are rare or not diagnosed in children."


Explore further

Children continue to be underrepresented in drug trials

More information: Abstract
Full Text (subscription or payment may be required)
Journal information: Pediatrics

Copyright © 2013 HealthDay. All rights reserved.

Citation: Most newly approved biologics studied in peds population (2013, January 15) retrieved 23 November 2020 from https://medicalxpress.com/news/2013-01-newly-biologics-peds-population.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
 shares

Feedback to editors

User comments