MHRA approves daily oral tablet Icotyde for plaque psoriasis
On 23 October 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved a new daily oral medicine called icotrokinra hydrochloride, sold under the brand name Icotyde, for people with moderate to severe plaque psoriasis. Plaque psoriasis is a condition that causes red, scaly, and itchy or painful patches of skin across the body, including the scalp, hands, feet, and nails. The approval applies to adults as well as adolescents aged 12 years and older who weigh at least 40 kg and qualify for systemic therapy. Approval came after four Phase 3 clinical trials involving 2,500 patients showed that taking a 200mg tablet once per day was effective compared to a placebo by week 16. The authorisation was granted to Janssen-Cilag Limited. The MHRA stated that full patient information leaflets will be available on its website within seven days of the announcement.
What was announced
The Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisation for icotrokinra hydrochloride (Icotyde) on 23 October 2026 to Janssen-Cilag Limited. The decision permits the use of this oral tablet in patients aged 12 and older who weigh at least 40 kg and suffer from moderate to severe plaque psoriasis. Eligible patients must also be candidates for systemic therapy, which refers to treatments that work throughout the entire body rather than on a single area of skin.
The regulatory agency evaluated data from four Phase 3 clinical trials that included 2,500 participants with the skin condition. Among those enrolled were 72 young people aged 12 to 17 weighing at least 40 kg. Patients in these studies took a 200mg tablet once daily, and the trials measured results against a placebo at week 16.
What it means
Patients with moderate to severe plaque psoriasis have another authorized oral option. Plaque psoriasis produces red, scaly skin patches that can itch or cause pain, affecting regions such as the scalp, genitals, hands, feet, and nails.
The medicine works by selectively binding to and blocking the IL-23 receptor. IL-23 is a protein involved in immune and inflammatory responses that can drive chronic inflammation in conditions like psoriasis. By blocking this specific target, the drug aims to reduce inflammatory activity. The MHRA plans to monitor the safety of icotrokinra hydrochloride through its Yellow Card scheme, where patients and healthcare professionals can report suspected side effects.
What the announcement does not tell us
The announcement does not state when Icotyde will become available to prescription holders in the UK, nor does it give the financial cost of the medication. It does not mention whether the National Institute for Health and Care Excellence (NICE) will recommend it for NHS use.
Specific side effects observed during the clinical trials are not listed in the press release. Patients seeking information on side effects, contraindications, or specific safety warnings will need to wait for the Summary of Product Characteristics and Patient Information leaflets, which the MHRA expects to publish on its website within seven days.
How this was written
This analysis was written with AI from the official announcement below, using only facts that announcement states. The quoted wording is gov.uk: Medicines and Healthcare products Regulatory Agency’s own. Always check the original before acting on anything here.
MHRA approves new oral treatment for moderate to severe plaque psoriasis
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