Janssen Seeks FDA Nod for Stelara in Juvenile PsA

The supplemental Biologics License Application is supported by extrapolation of data from nine studies across both adult trials in active PsA and adult and pediatric studies in moderate to severe plaque psoriasis, totaling 3,997 patients evaluated across these closely associated diseases. 

Janssen is seeking expanded approval of Stelara (ustekinumab) for pediatric patients aged five and older with juvenile psoriatic arthritis (jPsA).

The company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA). The filing is supported by extrapolation of data from nine studies across both adult trials in active PsA and adult and pediatric studies in moderate to severe plaque psoriasis, totaling 3,997 patients evaluated across these closely associated diseases. 

Data extrapolation is the process of estimating response, trends or effects based on previous observations from patients with closely related conditions. With the limited availability of pediatric patients for clinical trial inclusion, researchers can extrapolate data from trials with adults to determine the potential efficacy and tolerability of a treatment for a pediatric population. A decision from the U.S. FDA is anticipated in late 2022.

"As children and their families manage the debilitating symptoms of juvenile psoriatic arthritis, it is critical that their physicians have a breadth of treatment options to consider," says Alyssa Johnsen, MD, PhD, Vice President, Rheumatology Disease Area Leader, Janssen Research & Development, LLC, in a news release. "With this latest submission, we're excited to work with the U.S. FDA to evaluate this potential therapeutic option that could help meet the needs of children living with psoriatic arthritis."

Since receiving approval in September 2009 for the treatment of adults living with moderate to severe plaque psoriasis, Stelara has received approval for four additional indications: children (ages 6 and older) with moderate to severe plaque psoriasis, adults with active PsA, adults with moderately to severely active Crohn's disease and adults with moderately to severely active ulcerative colitis.