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."

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

add to favorites email to friend print save as pdf

Related Stories

Children continue to be underrepresented in drug trials

Jul 23, 2012

(HealthDay) -- Even for conditions with a high pediatric disease burden, only a small proportion of clinical drug trials study pediatric patients, according to research published online July 23 in Pediatrics.

Federal laws have enhanced pediatric drug studies

Feb 29, 2012

Federal laws that motivate or require drug and biologic developers to conduct pediatric studies have yielded beneficial information to guide the use of medications in children, says a new report by the Institute of Medicine. ...

Study exposes need for pediatric cardiac devices

Mar 30, 2009

Nearly two-thirds of children who undergo routine interventional cardiology procedures -- those involving a catheter to treat structural disorders of the heart -- may be receiving treatment with a device that's being used ...

Recommended for you

Helping parents understand infant sleep patterns

Dec 19, 2014

Most parents are not surprised by the irregularity of a newborn infant's sleep patterns, but by six months or so many parents wonder if something is wrong with their baby or their sleeping arrangements if ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.