EMA recommends marketing authorization of icotrokinra for adults and adolescents with plaque psoriasis

On July 24, 2026, the European Medicines Agency (EMA) recommended granting marketing authorization for icotrokinra, an oral therapy targeting the interleukin-23 (IL-23) receptor, for adults and adolescents aged ≥12 years weighing ≥40 kg with moderate-to-severe plaque psoriasis. The Committee for Medicinal Products for Human Use (CHMP) opinion will now be sent to the European Commission (EC) for a decision on marketing authorization across the European Union (EU). This recommendation follows the earlier approval of icotrokinra by the U.S. Food and Drug Administration (FDA).

In reaching its opinion, the EMA considered data from four phase III trials involving 2,500 patients with moderate-to-severe plaque psoriasis. In three studies, after 16 weeks, 50–57% of patients receiving icotrokinra achieved ≥90% improvement in the Psoriasis Area and Severity Index (PASI 90), compared with 1–4% receiving placebo. Investigator’s Global Assessment (IGA) scores of 0 or 1, indicating clear or almost clear skin, were achieved by 65–71% and 8–11% of patients, respectively. The fourth study included patients with psoriasis affecting the scalp, genital region, hands, and feet. Icotrokinra demonstrated a manageable safety profile; fungal infections were the most frequent adverse event (AE), occurring in 1.1% of patients.