Johnson & Johnson (NYSE:JNJ) announced that the U.S. FDA has granted approval for Tremfya (guselkumab) to treat children aged six and older, weighing at least 40 kg, and suffer from moderate to severe plaque psoriasis and active psoriatic arthritis.
The company said that this approval marks Tremfya as the first IL-23 inhibitor authorized for these pediatric uses, following its initial FDA approvals for adults with moderate to severe plaque psoriasis in 2017 and active psoriatic arthritis in 2020.
The approval was based on the study, which showed that pediatric patients treated with Tremfya achieved significant skin clearance compared to those receiving a placebo.
Tremfya, a monoclonal antibody treatment, is also approved in adults with moderate to severely active ulcerative colitis and Crohn’s disease.