EMA backs Icotyde as first oral IL-23 receptor treatment for plaque psoriasis

If authorised by the European Commission, Icotyde would provide eligible adults and adolescents with an oral alternative to existing injectable treatments targeting the IL-23 pathway.

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

The positive opinion moves the first oral medicine targeting the interleukin-23 receptor closer to European availability, although final authorisation and national pricing and reimbursement decisions are still required.

Field	Content
Alert Type	Industry Update
Topic	Regulatory recommendation and oral plaque 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, the Committee for Medicinal Products for Human Use adopted a positive opinion recommending marketing authorisation for Icotyde. The proposed indication covers moderate-to-severe plaque psoriasis in adults and adolescents aged 12 years and older weighing at least 40 kg who are candidates for systemic therapy. The recommendation is not yet an EU marketing authorisation and will be referred to the European Commission for a final decision.
Why It Matters	Icotyde is an oral synthetic peptide that selectively targets the interleukin-23 receptor. If authorised, it would become the first oral medicine targeting the IL-23 pathway in the EU, potentially broadening treatment choice for patients who currently receive injectable medicines acting on the same pathway.
Supporting Context	The CHMP assessment included four Phase 3 studies involving nearly 2,500 adults and adolescents. EMA reported that the treatment reduced disease severity and skin involvement; fungal infections were the most commonly reported adverse effect.
Who Is Most Affected	Dermatologists and eligible patients would be most directly affected by the potential availability of an oral IL-23 receptor-targeted treatment. National payers and health technology assessment bodies would determine pricing, reimbursement and positioning within local treatment pathways following any European Commission authorisation.
Industry Impact	Authorisation could increase competition within the moderate-to-severe psoriasis market and expand the use of IL-23-targeted treatment beyond injectable products. Its practical effect would depend on the final label, comparative clinical positioning, national reimbursement and adoption in practice.
Key Takeaway	The CHMP opinion moves the first oral IL-23 receptor-targeted psoriasis medicine closer to EU authorisation, but Icotyde is not yet approved.
What to Watch	The European Commission’s final marketing-authorisation decision, publication of the approved product information and subsequent pricing and reimbursement decisions across EU Member States.
Primary Source	European Medicines Agency: Icotyde
Relevant Date	23 July 2026 — positive CHMP opinion

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