EMA's CHMP recommends first oral IL-23 receptor drug for psoriasis and implant-based treatment for wet AMD

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisations for two significant new treatments following its meeting from 20-23 July 2026: Icotyde (icotrokinra) for moderate-to-severe plaque psoriasis and Susvimo (ranibizumab) for neovascular age-related macular degeneration (nAMD).

According to the EMA meeting highlights, the CHMP recommended twelve new medicines for approval overall, along with extensions for eight others (ema.europa.eu).

Icotyde, from Janssen-Cilag International N.V., is recommended for adults and adolescents from 12 years of age weighing at least 40 kg with moderate-to-severe plaque psoriasis. It is the first oral medicine targeting the interleukin-23 (IL-23) receptor. The active substance icotrokinra blocks the IL-23 receptor, reducing inflammation and associated symptoms. Injectable IL-23-targeting medicines are already available in the EU, but this would be the first oral option in the pathway (ema.europa.eu).

Plaque psoriasis is a chronic inflammatory skin disease affecting around 1% to 4% of adults and up to 1% of children worldwide, with significant physical and psychological impacts. The recommendation draws on data from four phase 3 trials involving about 2,500 patients. In three studies, 50% to 57% of patients on Icotyde achieved PASI 90 (at least 90% improvement in Psoriasis Area and Severity Index scores) at 16 weeks, versus 1% to 4% on placebo. Between 65% and 71% achieved an Investigator’s Global Assessment score of 0 or 1 (clear or almost clear skin), compared with 8% to 11% on placebo. A fourth study covered difficult-to-treat areas such as the scalp, genitals, hands and feet. The most common side effects were fungal infections, occurring in 1.1% of patients (ema.europa.eu).

Separately, the CHMP recommended Susvimo (ranibizumab) from Roche Registration GmbH for adults with nAMD whose disease is stable after responding to prior intravitreal VEGF inhibitor treatment. It is used only with a surgically inserted refillable ocular implant that continuously releases the medicine and is refilled every six months. This is the first such implant approved in the EU and offers an alternative to frequent (typically monthly) intravitreal injections (ema.europa.eu).

nAMD is an advanced form of age-related macular degeneration, a leading cause of central vision loss in people over 50. Existing ranibizumab injections have been authorised since 2007 but require regular administration that can burden patients and affect compliance. A phase 3 study of 415 patients showed Susvimo maintained visual and anatomical outcomes comparable to monthly intravitreal ranibizumab. Common side effects included iritis, conjunctival bleb or leak, cataract, vitreous floaters, conjunctival haemorrhage, hyperaemia, eye pain and headache (ema.europa.eu).

Roche noted the recommendation is based on the Archway phase 3 trial and supportive LADDER and Portal studies, with data supporting vision maintenance equivalent to monthly injections and longer-term outcomes up to seven years, with about 95% of patients needing no supplemental anti-VEGF treatment with two refills per year (roche.com).

Both opinions are intermediate steps. They will be forwarded to the European Commission for decisions on EU-wide marketing authorisations. Pricing and reimbursement decisions will then occur at member state level.

The recommendations form part of broader CHMP activity in July 2026, which also included positive opinions for other new medicines such as lipid-lowering therapies and an orphan drug for cerebral adrenoleukodystrophy, alongside three negative opinions (ema.europa.eu). Specialist outlets including The Pharma Letter reported the full list of recommendations (thepharmaletter.com).