FDA nod for Tremfya in pediatric plaque psoriasis and active psoriatic arthritis

29 September 2025

The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s (NYSE: JNJ) Tremfya (guselkumab) to treat children six years and older who also weigh at least 40 kg with moderate to severe plaque psoriasis (PsO), who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis (PsA).

This milestone makes Tremfya the first and only IL-23 inhibitor approved for these pediatric indications and builds on the initial FDA approvals in adults living with moderate to severe plaque PsO in 2017 and active PsA in 2020. 

An established treatment option with proven safety and demonstrated efficacy

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