EMA recommends Icotyde for EU authorisation in moderate-to-severe plaque psoriasis

If authorised, Icotyde would become the first oral treatment targeting the interleukin-23 receptor available to eligible adults and adolescents in the EU.

The European Medicines Agency’s human medicines committee has recommended granting EU marketing authorisation to Janssen-Cilag’s Icotyde (icotrokinra) for moderate-to-severe plaque psoriasis in adults and adolescents aged 12 years and older weighing at least 40 kg.

The positive opinion introduces the prospect of an oral interleukin-23 receptor-targeted treatment, but a European Commission decision and national pricing and reimbursement assessments are still required before patient access.

Field	Content
Alert Type	Industry Update
Topic	Regulatory recommendation and psoriasis treatment
Organisation(s)	European Medicines Agency; Committee for Medicinal Products for Human Use; Janssen-Cilag International N.V.
Affected Stakeholders	Dermatologists, eligible adults and adolescents with plaque psoriasis, Janssen-Cilag, payers and national reimbursement authorities
Therapy Area(s)	Dermatology; plaque psoriasis
Geography	European Union
What Happened	On 23 July 2026, EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending EU marketing authorisation for Icotyde for moderate-to-severe plaque psoriasis in adults and adolescents aged 12 years and older weighing at least 40 kg. The recommendation is not a marketing authorisation: it will be referred to the European Commission for a final decision.
Why It Matters	Icotyde blocks the interleukin-23 receptor and would be the first authorised oral medicine targeting the interleukin-23 pathway in the EU. This could provide an additional treatment format for eligible patients alongside existing injectable medicines targeting the pathway.
Supporting Context	EMA assessed four Phase 3 trials involving approximately 2,500 patients. Across three studies, 50% to 57% of patients receiving Icotyde achieved PASI 90 after 16 weeks, compared with 1% to 4% receiving placebo; a fourth study included psoriasis affecting difficult-to-treat areas.
Who Is Most Affected	Dermatologists and eligible patients would be most directly affected by the potential addition of an oral interleukin-23 receptor-targeted treatment. Payers and national health authorities will subsequently determine pricing and reimbursement if the European Commission grants authorisation.
Industry Impact	If authorised, Icotyde could increase competition in the moderate-to-severe psoriasis market and broaden treatment choice for patients who may prefer an oral medicine. Its practical impact will depend on the final authorised indication, national reimbursement decisions and adoption in clinical practice.
Key Takeaway	The positive CHMP opinion moves the first oral interleukin-23 receptor-targeted psoriasis treatment closer to EU authorisation, but it is not yet approved.
What to Watch	The European Commission’s marketing-authorisation decision, followed by pricing and reimbursement decisions in individual EU Member States.
Primary Source	European Medicines Agency announcement
Relevant Date	23 July 2026 — positive CHMP opinion

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