psoriasis
THURSDAY, Oct. 2, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Tremfya (guselkumab) for the treatment of plaque psoriasis and active psoriatic arthritis in children 6 years of age and older.
The approval is for pediatric patients living with either moderate-to-severe plaque psoriasis, who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis. This approval expands indications of use beyond the initial adult population and is the first and only pediatric approval for an interleukin-23 inhibitor.
The approval is based on results from the phase 3 PROTOSTAR study in which the coprimary end points of Psoriasis Area Severity Index (PASI) 90 and Investigator's Global Assessment (IGA) score of 0/1 were achieved at week 16. Mo