July 24, 2026 — The European Medicines Agency (EMA) has recommended granting a marketing authorisation in the European Union for Icotyde (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in adults and adolescents aged 12 years and older weighing at least 40 kg.
Plaque psoriasis is a chronic inflammatory skin disease affecting approximately 1% to 4% of adults and up to 1% of children worldwide. It significantly impacts quality of life, causing both physical and psychological distress.
While several injectable biologics targeting interleukin-23 (IL-23) are already available in the EU, Icotyde is the first oral medicine to target the IL-23 pathway, offering a more convenient treatment option. The active substance, icotrokinra, blocks the IL-23 receptor, reducing inflammation and symptoms associated with the disease.
EMA's opinion was based on data from four Phase 3 trials involving 2,500 patients. In three pivotal studies, after 16 weeks of treatment, 50% to 57% of patients receiving Icotyde achieved PASI 90 (at least 90% improvement in symptom scores), compared with 1% to 4% for placebo. Additionally, 65% to 71% of Icotyde-treated patients achieved clear or almost clear skin (IGA 0/1), versus 8% to 11% for placebo. A fourth study focused on patients with psoriasis in hard-to-treat areas including the scalp, genitals, hands and feet.
Icotyde demonstrated a favorable safety profile, with the most common side effect being fungal infections, occurring in 1.1% of patients.
The CHMP opinion will now be forwarded to the European Commission for final decision on EU-wide marketing authorisation. Pricing and reimbursement will be determined by individual Member States. The applicant is Janssen-Cilag International N.V.
