The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized a once-daily tablet for eligible people with moderate-to-severe plaque psoriasis, adding an oral treatment option for adults and adolescents who qualify for systemic therapy.
The approval for icotrokinra hydrochloride, sold as Icotyde, was granted to Janssen-Cilag Limited on Oct. 23. It covers adults and adolescents aged 12 and older who weigh at least 40 kilograms and are candidates for systemic treatment.
Plaque psoriasis causes red, scaly patches that can itch or hurt. The MHRA says these patches may affect the scalp, genitals, hands, feet and nails.
The authorization rested on results from four Phase 3 studies, which enrolled 2,500 people with moderate-to-severe plaque psoriasis. The group included 72 adolescents ages 12 to 17 who weighed at least 40 kilograms. At the 16-week mark, each trial found the medicine effective compared with a placebo among the populations studied.
Icotyde is taken as one 200-milligram tablet daily. It works by blocking the IL-23 receptor, which is involved in immune and inflammatory responses. The MHRA says IL-23 can contribute to the chronic inflammation associated with psoriasis and other immune-mediated diseases.
Julian Beach, the MHRA’s executive director of operations, called the authorization “another treatment option” for patients. The agency said it will keep reviewing the medicine’s safety and asked patients and health care professionals to report suspected side effects through its Yellow Card scheme.
The MHRA said product information and patient leaflets are due to appear on its products website within seven days of approval.
