MHRA approves new oral treatment for moderate to severe plaque psoriasis

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved icotrokinra hydrochloride (Icotyde) for the treatment of moderate to severe plaque psoriasis in adults and adolescents aged 12 years and older who weigh at least 40 kg and are candidates for systemic therapy. 

Plaque psoriasis is an inflammatory condition that causes red, scaly and often itchy or painful patches of skin. It can affect areas including the scalp, genitals, hands and feet, as well as the nails. 

The MHRA’s approval was supported by data from four Phase 3 clinical trials involving 2,500 people with moderate to severe plaque psoriasis, including 72 adolescents aged 12 to under 18 years weighing at least 40 kg. 

At week 16, all four studies demonstrated icotrokinra hydrochloride’s efficacy in treating moderate to severe plaque psoriasis when compared with placebo in the populations studied. 

Julian Beach, Executive Director, Operations, said: 

“Today’s authorisation provides another treatment option for patients living with moderate to severe plaque psoriasis. 

“As with all newly authorised medicines, the safety of icotrokinra hydrochloride will continue to be closely monitored by the MHRA, and we encourage patients and healthcare professionals to report any suspected side effects through the Yellow Card scheme.” 

The medicine works by selectively binding to and blocking the IL-23 receptor. IL-23 is involved in inflammatory and immune responses and can contribute to the chronic inflammation associated with immune-mediated diseases such as psoriasis. 

Icotrokinra hydrochloride is taken as a 200mg tablet once a day. Patients should follow the instructions in the Patient Information Leaflet. 

Patients should always take medicines exactly as prescribed and speak to their doctor or pharmacist if they have questions about their treatment. 

Authorisation for icotrokinra hydrochloride (Icotyde)was granted on 23 October 2026 to Janssen-Cilag Limited.