MHRA licenses J&J's once-daily icotrokinra pill for moderate to severe plaque psoriasis

The MHRA authorised Johnson & Johnson's icotrokinra (Icotyde) on 23 October 2026 for moderate to severe plaque psoriasis in adults and adolescents aged 12 and over who weigh at least 40 kg and are candidates for systemic therapy. The licence was granted to Janssen-Cilag Limited ¹.

The UK decision follows the European Commission's marketing authorisation, which J&J announced on 21 September 2026 ². Icotrokinra is an oral peptide that binds to and blocks the IL-23 receptor, and patients take a single 200mg tablet each day ¹. J&J describes it as the first targeted oral peptide to block that receptor ².

What the trials found

The MHRA based its approval on four Phase 3 trials covering 2,500 people, 72 of them adolescents aged 12 to under 18. In all four, icotrokinra beat placebo at week 16 ¹.

J&J's account of the ICONIC programme gives more detail. ICONIC-LEAD randomised 684 participants, 456 to icotrokinra and 228 to placebo, with PASI 90 and an IGA score of 0 or 1 as co-primary endpoints, and enrolled 66 adolescents. ICONIC-TOTAL took 311 participants with disease at high-impact sites such as the scalp, genitals, hands and feet. ICONIC-ADVANCE 1 and 2 compared the drug with both placebo and deucravacitinib, another oral psoriasis treatment ².

In those two head-to-head studies, about 70% of patients on icotrokinra reached clear or almost clear skin on the IGA scale and 55% reached PASI 90 at week 16. Adverse reaction rates were within 1.1% of placebo through week 16, and J&J reported no new safety signals through week 52 ².

What it means for the market

The approval gives UK prescribers a daily pill acting on the IL-23 pathway, a mechanism that has so far reached psoriasis patients mainly through injected biologics. J&J's case for the product rests on that convenience. It says most people with moderate to severe plaque psoriasis are eligible for systemic treatment but are not receiving it, and it estimates that 6.4 million people in Europe live with the condition ².

For competitors, the comparator matters. Two of the four Phase 3 trials pitted icotrokinra against deucravacitinib, so the evidence package includes a direct comparison with an existing oral option rather than placebo alone ². J&J says it is working with stakeholders across Europe on patient access ². Neither source gives a UK price or a NICE appraisal timetable, so whether and when NHS patients can get the drug routinely is still unknown.

The pipeline extends beyond the skin. J&J is running Phase 3 studies of icotrokinra in active psoriatic arthritis, ulcerative colitis and Crohn's disease. The drug was jointly discovered with Protagonist Therapeutics, and J&J holds exclusive worldwide rights from Phase 2 onwards ².

Caveats

Most of the efficacy figures above come from the company rather than the regulator, and the MHRA's own statement reports only that all four studies met their week 16 comparisons with placebo ¹. Safety follow-up in the pooled data runs to 52 weeks ². Julian Beach, the MHRA's executive director of operations, said the agency would keep the medicine's safety "closely monitored", and asked patients and clinicians to report suspected side effects through the Yellow Card scheme ¹. The Summary of Product Characteristics is due on the MHRA Products website within 7 days of approval ¹.