The Medicines and Healthcare products Regulatory Agency (MHRA) has approved icotrokinra hydrochloride (Icotyde) tablets for the treatment of moderate to severe plaque psoriasis in adults and adolescents aged 12 years and older.
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.
All four studies demonstrated icotrokinra hydrochloride’s efficacy in treating moderate to severe plaque psoriasis.
The authorisation for Icotyde was granted to Janssen-Cilag Limited on Friday (23). The medicine works by selectively binding to and blocking the IL-23 receptor, which is involved in inflammatory and immune responses.
They can contribute to the chronic inflammation associated with immune-mediated diseases such as psoriasis.
Icotrokinra hydrochloride is taken as a 200mg tablet once a day and patients should follow the instructions in the Patient Information Leaflet.
They should speak to their doctor or pharmacist if they have questions about their treatment.
Julian Beach, Executive Director, Operations, said this authorisation provides another treatment option for plaque psoriasis patients.
“As with all newly authorised medicines, the safety of icotrokinra hydrochloride will continue to be closely monitored by the MHRA, and we encourage patients and healthcare professionals to report any suspected side effects through the Yellow Card scheme.”
