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

Britain's medicines regulator has approved Johnson & Johnson's daily oral pill Icotyde for adults and teenagers with moderate-to-severe plaque psoriasis. The Medicines and Healthcare Products Regulatory Agency (MHRA) cleared the drug for people aged 12 and older who weigh at least 40 kg. Approval rests on four late‑stage trials involving 2,500 patients, including 72 teenagers aged 12 to under 18. In each study, participants taking Icotyde showed better outcomes after 16 weeks compared with those on placebo. Icotyde, chemically known as icotrokinra, was already approved in the United States earlier this year for the same condition. The pill is produced in partnership with Protagonist Therapeutics, and J&J is testing it for ulcerative colitis, psoriatic arthritis and Crohn's disease. The company projects peak sales of about $5 billion across its intended uses. Icotyde will compete with established psoriasis drugs such as Bristol Myers Squibb's Sotyktu and AbbVie's Skyrizi.

Context

Plaque psoriasis is a chronic inflammatory skin disorder that affects millions worldwide and often requires long‑term treatment. Most existing therapies are injectable biologics, so an effective oral option offers a convenient alternative for patients.