The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Icotyde (icotrokinra hydrochloride) to treat moderate-to-severe plaque psoriasis in adults and adolescents aged 12 years and older who weigh at least 40kg and are candidates for systemic therapy.
Plaque psoriasis is an inflammatory condition that causes red, scaly and often itchy or painful patches of skin. It can affect areas including the scalp, genitals, hands and feet, as well as the nails.
The MHRA’s approval was supported by data from four phase 3 clinical trials involving 2,500 people with moderate-to-severe plaque psoriasis, including 72 adolescents aged 12 to under 18 years weighing at least 40kg.
At week 16, all four studies demonstrated Icotyde’s efficacy in treating moderate-to-severe plaque psoriasis when compared with placebo. Icotyde is taken as a 200mg tablet once a day.
Julian Beach, MHRA Executive Director Operations, said: “This authorisation provides another treatment option for patients living with moderate-to-severe plaque psoriasis. As with all newly authorised medicines, the safety of Icotyde will continue to be closely monitored by the MHRA.”
The medicine works by selectively binding to and blocking the IL-23 receptor. IL-23 is involved in inflammatory and immune responses and can contribute to the chronic inflammation associated with immune-mediated diseases such as psoriasis.