The European Medicines Agency has recommended granting a marketing authorisation for Icotyde (icotrokinra), the first oral medicine targeting the interleukin-23 (IL-23) pathway, for the treatment of moderate-to-severe plaque psoriasis in adults and adolescents from 12 years of age weighing at least 40 kg.
Plaque psoriasis is a common chronic inflammatory skin disease affecting around 1% to 4% of adults and up to 1% of children worldwide. The condition causes raised, scaly patches on the skin that can be itchy and painful, and it can have a significant impact on people’s quality of life, causing both physical and psychological discomfort. Although a range of treatments is available, there remains a need for effective, safe and convenient options. Many patients do not achieve adequate control of their symptoms, the effects of treatment can wane over time, and some patients experience significant side effects.
The active substance in Icotyde, icotrokinra, works by blocking the receptor for interleukin-23, a protein that plays a role in the inflammation seen in plaque psoriasis. By blocking the action of IL-23, icotrokinra reduces inflammation and the symptoms associated with the disease. While authorised injectable medicines targeting interleukin-23 are available in the EU, Icotyde is the first authorised oral medicine targeting this pathway.
EMA considered data from four phase 3 trials involving 2,500 patients with moderate-to-severe plaque psoriasis. In three of these studies, after 16 weeks, between 50% and 57% of patients who took Icotyde achieved PASI 90 — a 90% or greater reduction in symptom scores as measured by the Psoriasis Area and Severity Index — compared with between 1% and 4% of patients who took placebo. Between 65% and 71% of patients on Icotyde achieved an IGA score of 0 or 1, meaning their skin was clear or almost clear of psoriasis lesions, compared with 8% to 11% on placebo. A fourth study involved patients with psoriasis affecting difficult-to-treat areas such as the scalp, genital region, hands and feet.
Icotyde has a favourable safety profile. The most common side effects reported were fungal infections, occurring in 1.1% of patients.
The CHMP opinion will now be forwarded to the European Commission for a final decision on EU-wide marketing authorisation. Once granted, pricing and reimbursement will be determined at the level of each member state.
Source: EMA News
