EU Approves First Oral Treatment for Moderate to Severe Psoriasis

The European Union has approved Icotyde, a new daily oral medication for adults and adolescents aged 12 and over suffering from moderate to severe psoriasis. Developed by Johnson & Johnson, the drug contains icotrokinra, which targets the IL-23 protein pathway, a key driver of the inflammatory process in psoriasis. This marks the first oral treatment approved in Europe that directly targets this pathway, offering a more convenient alternative to existing injectable therapies for some patients.

The approval follows four Phase 3 clinical trials involving approximately 2,500 participants. These studies demonstrated significant skin improvement in a large proportion of patients within four months, including in difficult-to-treat areas like the scalp, genitals, palms, and soles. The drug is intended for individuals weighing at least 40 kilograms who require systemic treatment.

While Icotyde offers a promising new option, it is not a cure for psoriasis and requires ongoing monitoring for long-term efficacy and safety. Common side effects reported to the European Medicines Agency include fungal infections in about 1.1% of patients. Due to its impact on the immune system, patients must undergo screening for tuberculosis and assess their vaccination status before starting treatment. Those with active infections may need to postpone treatment.

The drug received FDA approval in the United States in March and is now available in more countries. As of September 23, 2026, a launch date for Israel has not been announced. The medication must undergo a registration process with the Israeli Ministry of Health, and its inclusion in the public health basket will be a separate consideration.