Janssen seeks FDA approval of ustekinumab for juvenile psoriatic arthritis
Ustekinumab, a biologic targeting cytokines interleukin 12 and 23, has been submitted for expanded approval in the treatment of juvenile psoriatic arthritis in pediatric patients aged 5 years and older, according to a press release.
The application for approval is based on data extrapolation from nine studies including 3,997 patients across adult trials in active psoriatic arthritis (PsA) and adult and pediatric studies in moderate to severe plaque psoriasis.
Ustekinumab (Stelara, Janssen) was originally approved in 2009 for the treatment of moderate to severe plaque psoriasis in adults. It has since received expanded approval for the treatment of active PsA in adults, moderately to severely active Crohn’s disease in adults, moderately to severely active ulcerative colitis in adults, and moderate to severe plaque psoriasis in pediatric patients aged 6 years and older.
"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,” Alyssa Johnsen, MD, PhD, vice president and rheumatology disease area leader at Janssen Research & Development, said in the 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."
An FDA decision is expected by late 2022.