The European Commission has approved Johnson & Johnson’s Icotyde (icotrokinra) for adults and adolescents aged 12 years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy, following a positive CHMP opinion in July. The once-daily oral IL-23 receptor antagonist was previously approved by the US FDA in March 2026.
The authorization is supported by J&J’s Phase III ICONIC program, including head-to-head studies in which icotrokinra outperformed Bristol Myers Squibb’s oral TYK2 inhibitor Sotyktu (deucravacitinib). Icotyde is the first approved oral therapy to directly target the IL-23 receptor. The decision positions icotrokinra as the first oral therapy to directly block the IL-23 receptor — a mechanism previously accessible only through injectable biologics — and extends the drug's regulatory footprint following its US FDA approval in March 2026.
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