Johnson & Johnson has taken a significant step toward revolutionizing the treatment of moderate-to-severe plaque psoriasis with the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for icotrokinra. This investigational oral peptide is a first-in-class medicine, uniquely designed to selectively block the IL-23 receptor, a key driver of inflammation in plaque psoriasis and potentially other IL-23-mediated diseases. The company aims to provide a new, highly effective, and convenient therapeutic option for both adults and pediatric patients aged 12 and older.
The NDA is backed by an unprecedented and comprehensive data package derived from four pivotal Phase 3 studies within the ICONIC clinical development program: ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 & 2. Across these studies, icotrokinra consistently met all primary and co-primary endpoints, demonstrating remarkable efficacy in achieving significant skin clearance. This includes positive outcomes even in traditionally difficult-to-treat areas like the scalp and genitals, as highlighted by data from the ICONIC-TOTAL study. Furthermore, the ICONIC-ADVANCE studies showcased icotrokinra's superiority to deucravacitinib in head-to-head comparisons, underscoring its potential as a leading oral treatment.
Beyond its efficacy, icotrokinra has also shown a favorable safety profile. Pooled safety data from the trials indicated a similar proportion of adverse events between the icotrokinra and placebo groups, with no new safety signals identified to date. This robust safety profile, combined with the simplicity of a once-daily oral pill, is a crucial factor in its potential to transform patient care.
Johnson & Johnson believes that icotrokinra has the capacity to shift the treatment paradigm for plaque psoriasis. The rapid patient enrollment in the ICONIC program itself reflects the high unmet need for advanced, patient-centric treatments. As Liza O'Dowd, Vice President, Immunodermatology and Respiratory Disease Area Lead at Johnson & Johnson Innovative Medicine, stated, the extensive studies and robust results instill confidence that icotrokinra can establish a new standard in managing this chronic immune-mediated disease. The company is also exploring the long-term benefits with ongoing studies, including a Phase 3 study (ICONIC-ASCEND) directly comparing icotrokinra to an injectable biologic, ustekinumab, further emphasizing its commitment to advancing psoriasis research.