Guselkumab approved by EC for children with plaque psoriasis

On December 19, 2025, the European Commission (EC) extended the marketing authorization for the interleukin-23 (IL-23) inhibitor guselkumab as a subcutaneous treatment for children and adolescents aged ≥6 years with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. This approval builds on the EC approval in adults living with moderate-to-severe plaque psoriasis in 2017. 

This approval is based on results from the phase III PROTOSTAR (NCT03451851) study in 120 pediatric patients with moderate-to-severe plaque psoriasis, along with bridging pharmacokinetic (PK) data from the phase III VOYAGE 1 (NCT02207231) and VOYAGE 2 (NCT02207244) studies in adults with moderate-to-severe plaque psoriasis. In PROTOSTAR, by Week 16, ~76% of patients receiving guselkumab achieved Psoriasis Area Severity Index (PASI) 75 vs 20% receiving placebo (p < 0.001). High levels of skin clearance were also observed, with the proportion of patients achieving Investigator’s Global Assessment (IGA) 0/1 at Week 16 also being superior in the guselkumab arm (66% vs 16%; p < 0.001). Nearly 40% of patients on guselkumab achieved complete clearance (IGA 0) at Week 16 vs 4% on placebo (p < 0.01). The safety profile for pediatric patients aged 6–17 years was consistent with that reported in adult plaque psoriasis studies.