The European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for Icotyde (icotrokinra) as a plaque psoriasis treatment, recommending marketing authorisation for adults and adolescents aged 12 years and older with moderate-to-severe disease — making it the first oral medicine targeting the interleukin-23 receptor to reach this stage in the EU.
The CHMP positive opinion, issued following the committee's meeting held July 20–23, 2026, covers icotrokinra for moderate-to-severe plaque psoriasis in patients aged 12 years and older weighing at least 40 kg who are candidates for systemic therapy. Johnson & Johnson, which is developing the asset through its Janssen Biotech subsidiary in collaboration with Protagonist Therapeutics, holds the marketing authorisation application. The recommendation marks the first time an oral IL-23 receptor antagonist has received a CHMP positive opinion anywhere in the world, following the US FDA approval of Icotyde for the same indication in March 2026.
The recommendation is supported by the Phase III ICONIC program, in which icotrokinra demonstrated superiority over placebo and deucravacitinib across co-primary efficacy endpoints in adults with moderate-to-severe plaque psoriasis. In adolescents, the drug also achieved significantly higher skin clearance rates than placebo, with responses maintained through Week 52. Safety was favorable, with no new signals identified.
Icotrokinra is a targeted oral peptide that selectively blocks the IL-23 receptor, interrupting the IL-23–driven inflammatory cascade central to psoriasis pathogenesis. This mechanism is distinct from injectable IL-23 antibodies such as risankizumab (Skyrizi) and guselkumab (Tremfya), which target the cytokine itself, and from intracellular TYK2 inhibitors such as deucravacitinib.