Human medicines European public assessment report (EPAR): Icotyde, icotrokinra hydrochloride, Status: Opinion
Human medicines European public assessment report (EPAR): Icotyde, icotrokinra hydrochloride, Status: Opinion
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 23 July 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Icotyde, intended for the treatment of plaque psoriasis in adults and adolescents.
The applicant for this medicinal product is Janssen-Cilag International N.V.
Icotyde will be available as 200 mg film-coated tablets. The active substance of Icotyde is icotrokinra, an immunosuppressant and interleukin inhibitor (ATC code: L04AC28). Icotrokinra is a synthetic peptide that binds selectively to the IL-23 receptor (IL-23R) with high affinity and competitively antagonises the binding of IL-23.
The benefits of Icotyde are its ability to inhibit the IL-23/IL-23R-dependent release of proinflammatory cytokines leading to a decrease in disease severity and skin involvement, as shown in four phase 3 randomised, multi-centre, double-blind, placebo and/or active comparator-controlled studies involving nearly 2,500 adults and adolescents. The most common side effects are fungal infections.
The full indication is:
Icotyde is indicated for the treatment of moderate to severe plaque psoriasis in adults, and adolescents 12 years of age and older and weighing at least 40 kg, who are candidates for systemic therapy.
Icotyde should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.
CHMP summary of positive opinion for Icotyde
Adopted
Reference Number:
EMADOC-1829012207-57557
English (EN) (132.55 KB - PDF)
First published:
24/07/2026
View
Product details
Name of medicine
Icotyde
Active substance
icotrokinra hydrochloride
International non-proprietary name (INN) or common name
icotrokinra hydrochloride
Therapeutic area (MeSH)
Psoriasis
EMA product number
EMEA/H/C/006730
Marketing authorisation applicant
Janssen-Cilag International N.V.
Opinion adopted
23/07/2026
Opinion status
Positive
News on Icotyde
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2026
24/07/2026
First oral medicine targeting interleukin-23 receptor recommended for plaque psoriasis
24/07/2026
This page was last updated on
24/07/2026
Summary
On 23 July 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Icotyde, intended for the treatment of plaque psoriasis in adults and adolescents. The applicant for this medicinal product is Janssen-Cilag International N.V. Icotyde will be available as 200 mg film-coated tablets. The active substance of Icotyde is icotrokinra, an immunosuppressant and interleukin inhibitor (ATC code: L04AC28). Icotrokinra is a synthetic peptide that binds selectively to the IL-23 receptor (IL-23R) with high affinity and competitively antagonises the binding of IL-23. The benefits of Icotyde are its ability to inhibit the IL-23/IL-23R-dependent release of proinflammatory cytokines leading to a decrease in disease severity and skin involvement, as shown in four phase 3 randomised, multi-centre, double-blind, placebo and/or active comparator-controlled studies involving nearly 2,500 adults and adolescents. The most common side effects are fungal infections. The full indication is: Icotyde is indicated for the treatment of moderate to severe plaque psoriasis in adults, and adolescents 12 years of age and older and weighing at least 40 kg, who are candidates for systemic therapy. Icotyde should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis. Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.