Johnson & Johnson’s Icotyde (icotrokinra) has been approved in the UK for moderate-to-severe plaque psoriasis, offering a new oral treatment option for the chronic inflammatory skin disease, the company announced today.
The MHRA authorised the drug for patients aged 12 years and older who weigh at least 40 kg and are candidates for systemic therapy.
Icotrokinra is an oral peptide that selectively blocks the interleukin-23 (IL-23) receptor, a key component of the inflammatory pathway involved in psoriasis.
Trial results
The approval was supported by four phase 3 trials involving approximately 2,500 patients, including adolescents.
In head-to-head phase 3 studies, around 70% of patients receiving icotrokinra achieved clear or almost clear skin, while 55% achieved at least a 90% reduction in disease severity at Week 16, according to J&J.
The clinical programme also assessed skin clearance in difficult-to-treat areas, with 66% of patients with scalp psoriasis and 77% of those with genital psoriasis achieving clear or almost clear skin by Week 16.
How does the drug work?
The drug differs from other oral psoriasis treatments, such as Bristol Myers Squibb’s Sotyktu (deucravacitinib), which inhibits the TYK2 pathway.
Icotrokinra blocks the IL-23 receptor, similar to biologic treatments, but offers the convenience of an oral formulation.
Commenting on the European Commission’s approval, Lluís Puig, Professor of Dermatology, Universitat Autònoma de Barcelona, said there remained an “ongoing unmet need for additional treatment options”.
He added that icotrokinra combines high levels of skin clearance and a favourable safety profile with the “convenience of once-daily oral administration”.
However, its dosing requirements may be a consideration for patients. Icotrokinra must be taken once daily on an empty stomach, with patients required to wait at least 30 minutes before eating.
What comes next?
J&J is developing icotrokinra in collaboration with Protagonist Therapeutics and expects it to generate peak sales of $5bn across multiple indications, according to the company’s press release.
Beyond plaque psoriasis, icotrokinra is also being investigated for psoriatic arthritis, ulcerative colitis and Crohn’s disease, potentially expanding its commercial reach if these programmes prove successful.
Although UK approval marks an important milestone, NHS availability will depend on NICE’s technology appraisal, which is currently ongoing, and subsequent decisions on pricing and reimbursement.
Featured image: Askar on Adobe Stock
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