European Commission approves TREMFYA® (guselkumab) for the treatment of children with plaque psoriasis, marking the first paediatric indication for an IL-23 inhibitor [Yahoo! Finance]
Johnson & Johnson (JNJ)
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Source: Yahoo! Finance
The decision is supported by the Phase 3 PROTOSTAR study, where guselkumab demonstrated higher levels of skin clearance vs. placebo at Week 16. BEERSE, Belgium (19 December 2025) – Johnson & Johnson today announced that the European Commission (EC) has extended the marketing authorisation for TREMFYA ® (guselkumab) as a subcutaneous treatment to treat moderate to severe plaque psoriasis (Pso) in children and adolescents from the age of 6 years who are candidates for systemic therapy. ,a This milestone makes guselkumab the first IL-23 inhibitor approved for any paediatric indication, building on EC approval in adults living with moderate to severe plaque Pso in 2017. Almost one-third of Pso cases begin in childhood, and the inflamed, scaly plaques caused by chronic disease may be itchy or painful and can be highly stressful for children, leading to a potential long-term impact on those affected. Paediatric Pso has been associated with certain comorbidities, such as obesity, hypert
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