J&J's Icotyde adds EU approval for plaque psoriasis
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Johnson & Johnson’s ICOTYDE (icotrokinra) has received European Commission approval as the first oral therapy to directly target the IL-23 receptor for plaque psoriasis.
The European Commission has approved Johnson & Johnson’s ICOTYDE™ (icotrokinrа, JNJ-77242113) 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.
WHAT IS ICOTYDE™ (icotrokinra)?
ICOTYDE™ 200 mg is a prescription medicine used to treat moderate to severe plaque psoriasis in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg), who may benefit from taking injections or medicines by mouth (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).