EC approves icotrokinra for adults and adolescents with moderate-to-severe plaque PsO

On September 21, 2026, the European Commission (EC) granted approval for the marketing authorization of icotrokinra, an oral interleukin-23 (IL-23) receptor antagonist, for the treatment of patients aged ≥12 years and weighing ≥40 kg with moderate-to-severe plaque psoriasis (PsO).¹

This approval is supported by efficacy and safety results from the phase III ICONIC clinical development program, including ICONIC-LEAD (NCT06095115), ICONIC-TOTAL (NCT06095102), ICONIC-ADVANCE 1 (NCT06143878), and ICONIC-ADVANCE 2 (NCT06220604).¹ The program evaluated icotrokinra in both adults and adolescents (≥12 years and weighing ≥40 kg) with moderate-to-severe plaque PsO, including patients with high-impact site involvement.¹ In the head-to-head studies, ~70% of patients receiving icotrokinra attained an Investigators Global Assessment (IGA) score of 0 or 1 (clear or almost clear skin), with 55% of patients achieving ≥90% improvement from baseline in Psoriasis Area and Severity Index (PASI90) at Week 16. At Week 16, rates of adverse events (AEs) were similar between patients receiving icotrokinra and placebo, with no new safety signals observed through Week 52.¹

The ICONIC-PsA 1 (NCT06878404) and ICONIC-PsA 2 (NCT06807424) studies are underway to evaluate icotrokinra in patients with psoriatic arthritis (PsA).¹