EMA Backs Icotyde, First Oral IL-23R Psoriasis Drug

Key Takeaways

• CHMP recommended Icotyde (icotrokinra) for moderate-to-severe plaque psoriasis from age 12 (≥40 kg).
• EMA positioned it as the first oral IL-23 pathway medicine; injectable IL-23 drugs already exist in the EU.
• At week 16, PASI 90 rates were 50%–57% versus 1%–4% with placebo across three pivotal studies.
• Most common adverse event: fungal infections (1.1%). Applicant: Janssen-Cilag International N.V.

Icotyde at a glance

Field	Detail
Medicine	Icotyde (icotrokinra)
Applicant	Janssen-Cilag International N.V.
Regulator step	CHMP positive opinion (24 July 2026)
Indication sought	Moderate-to-severe plaque psoriasis, adults and adolescents ≥12 years (≥40 kg)
Mechanism	Oral interleukin-23 receptor blocker
Evidence base	Four Phase 3 trials; ~2,500 patients
Key week-16 efficacy	PASI 90 50–57% vs 1–4% placebo; IGA 0/1 65–71% vs 8–11%

What did EMA recommend?

EMA said plaque psoriasis affects about 1%–4% of adults and up to 1% of children worldwide and can impair quality of life. Injectable IL-23-targeted medicines are already authorised, but Icotyde would be the first oral medicine targeting that pathway if the Commission grants authorisation.

Agency detail: EMA's 24 July Icotyde plaque psoriasis announcement.

What did the Phase 3 programme show?

EMA considered four Phase 3 trials. In three studies, week-16 PASI 90 rates were 50%–57% with Icotyde versus 1%–4% with placebo, and IGA 0/1 (clear or almost clear) rates were 65%–71% versus 8%–11%. A fourth study enrolled patients with difficult-to-treat sites such as scalp, genital region, hands and feet.

Ongoing/related protocol examples include ClinicalTrials.gov NCT06807424 (icotrokinra).

How does this sit in the July CHMP package?

Icotyde was one of twelve new medicines recommended at the July 2026 CHMP plenary, listed alongside Susvimo and the obicetrapib oral lipid pair. Context: EMA CHMP 20–23 July 2026 highlights.

What remains uncertain?

CHMP opinion is not Commission approval. Long-term durability beyond week 16, comparative data versus injectable IL-23 inhibitors, and adolescent-specific safety follow-up will matter for labelling and HTA. Fungal-infection rates in broader practice need pharmacovigilance.

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Frequently Asked Questions

Primary Sources

1. EMA: First oral IL-23 receptor medicine for plaque psoriasis — 24 July 2026
2. EMA: CHMP meeting highlights 20–23 July 2026
3. ClinicalTrials.gov: icotrokinra study NCT06807424