Johnson & Johnson has submitted an application for European Medicines Agency (EMA) approval of icotrokinra to treat adults and adolescents with moderate-to-severe plaque psoriasis (Pso) who are 12 years of age and older.
Icotrokinra is an investigational targeted oral tablet that is designed to block the IL-23 receptor, which underpins the inflammatory response in Pso and offers potential in other IL-23-mediated diseases.
The treatment could potentially result in complete skin clearance for patients with moderate-to-severe plaque psoriasis. It is a once-daily tablet and, relative to comparators, has a favourable safety profile.
Presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting, the phase 3 ICONIC-LEAD study showed that icotrokinra successfully met the co-primary endpoints of an Investigator’s Global Assessment (IGA) score of 0/1 (clear or almost clear skin) and Psoriasis Area and Severity Index (PASI) of 90 compared to placebo at Week 16.
The application included data from four phase 3 studies that met all primary and co-primary endpoints.
“For people living with plaque psoriasis, the burden of disease goes far beyond the skin,” said Mark Graham, Senior Director, EMEA Therapeutic Area Head, Immunology Medical Affairs, Johnson & Johnson Innovative Medicine.
“This EMA filing represents an important step in our efforts to advance plaque psoriasis care by broadening treatment options. Icotrokinra has the potential to offer complete skin clearance with a favourable safety profile, and simplicity in a once-daily tablet, that allows patients to live their lives the way they’d like to.”
Johnson & Johnson is also conducting the phase 3 ICONIC-ASCENDf study, the first head-to-head study that compares the oral tablet, icotrokinra, to an injectable biologic, ustekinumab, and placebo, which is an important advance in psoriasis research.