UK approves Johnson & Johnson's oral psoriasis pill for moderate-to-severe plaque psoriasis

Britain's Medicines and Healthcare products Regulatory Agency approved Johnson & Johnson's daily oral pill Icotyde (icotrokinra) on October 23, 2026, for adults and adolescents aged 12 and older weighing at least 40 kg with moderate-to-severe plaque psoriasis. Based on four Phase 3 trials involving 2,500 participants, the drug, developed with Protagonist Therapeutics, expands J&J's immunology portfolio against rivals Bristol Myers Squibb and AbbVie, targeting $5 billion in peak sales.

UK MHRA approval of Icotyde

• ▪Icotyde was approved in the United States earlier in 2026 for moderate-to-severe plaque psoriasis, marking its first approved indication
• ▪The Medicines and Healthcare products Regulatory Agency approved Johnson & Johnson's daily oral drug Icotyde on October 23, 2026 for treating moderate-to-severe plaque psoriasis
• ▪The Medicines and Healthcare products Regulatory Agency approved Icotyde for adults and teenagers aged 12 and older who weigh at least 40 kg

Phase 3 trial results

• ▪In all four late-stage trials of icotrokinra, patients taking icotrokinra achieved better outcomes after 16 weeks compared to patients given a placebo
• ▪The MHRA's UK regulatory approval of Icotyde was based on four late-stage clinical trials involving approximately 2,500 people with plaque psoriasis

Adolescent patient eligibility criteria

• ▪Icotyde requires patients to be at least 12 years old and weigh a minimum of 40 kg to meet UK eligibility criteria
• ▪The four pivotal Phase 3 trials for icotrokinra included 72 adolescent patients aged 12 to under 18 years

Competing psoriasis treatments

• ▪Icotyde is an oral daily pill developed in collaboration between Johnson & Johnson and Protagonist Therapeutics
• ▪Icotyde competes with established psoriasis treatments including Bristol Myers Squibb's oral drug Sotyktu and AbbVie's Skyrizi

Peak sales revenue forecast

• ▪Johnson & Johnson expects icotrokinra to reach $5 billion in peak annual sales across multiple therapeutic indications
• ▪Plaque psoriasis causes red, scaly, and often itchy or painful skin patches