EU Regulator Backs First Oral IL-23 Receptor Drug for Plaque Psoriasis

On July 24, 2026, the European Medicines Agency recommended granting marketing authorisation for Icotyde (icotrokinra) to treat moderate-to-severe plaque psoriasis in adults and adolescents aged 12 and older. As the first oral medicine targeting the interleukin-23 receptor, Icotyde offers a convenient alternative to existing injectable therapies. Phase 3 trials involving 2,500 patients demonstrated significant efficacy, with up to 71% achieving clear or almost clear skin, alongside a favourable safety profile.

EMA Icotyde marketing authorisation recommendation

• ▪Icotyde is recommended for the treatment of moderate-to-severe plaque psoriasis in adults and adolescents from 12 years of age weighing at least 40 kg.
• ▪The European Medicines Agency recommended granting a marketing authorisation in the European Union for Icotyde (icotrokinra) on July 24, 2026.
• ▪Plaque psoriasis is a chronic inflammatory skin disease affecting 1% to 4% of adults and up to 1% of children worldwide.

Icotrokinra interleukin-23 receptor blockade

• ▪The active substance in Icotyde, icotrokinra, works by blocking the receptor for interleukin-23, a protein involved in plaque psoriasis inflammation.
• ▪By blocking the action of interleukin-23, icotrokinra reduces inflammation and symptoms associated with plaque psoriasis.

First oral IL-23 pathway medicine

• ▪While authorised injectable medicines targeting interleukin-23 are available in the European Union, Icotyde offers an oral alternative.
• ▪Icotyde will be the first authorised oral medicine targeting the interleukin-23 pathway in the European Union.

Phase 3 trial efficacy outcomes

• ▪In three phase 3 trials, 50% to 57% of patients taking Icotyde achieved a 90% or more drop in symptom scores after 16 weeks, compared to 1% to 4% taking placebo.
• ▪The European Medicines Agency evaluated data from four phase 3 trials involving 2,500 patients with moderate-to-severe plaque psoriasis.
• ▪A fourth phase 3 study evaluated Icotyde in patients with psoriasis affecting difficult-to-treat areas including the scalp, genital region, hands, and feet.

Favourable safety profile data

• ▪Icotyde demonstrated a favourable safety profile in clinical trials, with fungal infections reported as the most common side effect.
• ▪Fungal infections occurred in 1.1% of patients treated with Icotyde in clinical trials.

EU regulatory approval pathway

• ▪Following potential European Commission approval, decisions regarding Icotyde's pricing and reimbursement will be made by individual European Union Member States.
• ▪The Committee for Medicinal Products for Human Use opinion on Icotyde will be sent to the European Commission for an EU-wide marketing authorisation decision.
• ▪Janssen-Cilag International N.V. is the applicant for the marketing authorisation of Icotyde.

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