Stelara approved for pediatric plaque psoriasis
The FDA has expanded approval of Stelara to include the treatment of moderate to severe pediatric plaque psoriasis, Janssen Pharmaceutical announced in a press release.
Stelara (ustekinumab), which targets both interleukin-12 and interleukin-23, was previously approved for adult patients with moderate to severe plaque psoriasis or active psoriatic arthritis. The new indication allows its use in children aged 6 to 11 years old with skin lesions or plaques associated with moderate to severe psoriasis.
The approval was based on results of the CADMUS Junior study, in which 77% of patients achieved clear or almost clear skin at 12 weeks after two doses, the release said.
“We are thrilled that the latest approval for Stelara will bring an alternative class of medication to this patient population and that we are able to deliver on our promise to find meaningful solutions for people afflicted with immune-mediated diseases,” Lloyd Miller, MD, PhD, vice president, immunodermatology disease area leader, Janssen Research & Development, said in the release. “While Stelara is currently available for adults and adolescents 12 years and older, children with plaque psoriasis have had more limited treatment options.”