Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis

Core Insights - Johnson & Johnson has submitted a New Drug Application (NDA) for icotrokinra, a first-in-class oral peptide targeting the IL-23 receptor, aimed at treating moderate-to-severe plaque psoriasis in patients aged 12 and older [1][2][6] - The NDA is supported by data from four pivotal Phase 3 studies, demonstrating significant skin clearance and a favorable safety profile, with icotrokinra showing superiority over deucravacitinib [1][2][4] - The treatment offers a once-daily pill option, which may shift the treatment paradigm for plaque psoriasis patients [1][2][5] Phase 3 Studies Overview - The ICONIC clinical development program includes studies such as ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2, all of which met primary and co-primary endpoints [1][4][6] - ICONIC-LEAD involved 684 participants, showing significant improvements in skin conditions compared to placebo [3][4] - ICONIC-ASCEND is the first head-to-head study comparing icotrokinra with ustekinumab, an injectable biologic, marking a significant advancement in psoriasis research [2][4] Efficacy and Safety Data - Results from the ICONIC-ADVANCE studies confirmed icotrokinra's efficacy, achieving co-primary endpoints of Investigator's Global Assessment (IGA) score of 0/1 and Psoriasis Area and Severity Index (PASI) 90 [2][3][4] - Safety data pooled from all studies indicated a similar proportion of adverse events between icotrokinra (49.1%) and placebo (51.9%), with no new safety signals identified [1][2][4] Patient Impact and Market Potential - Approximately 8 million Americans and over 125 million people globally suffer from plaque psoriasis, with nearly one-quarter experiencing moderate-to-severe cases [5][6] - The introduction of icotrokinra could significantly improve the quality of life for patients, particularly those with difficult-to-treat areas such as the scalp and genitals [2][5][6] - The innovative oral formulation may appeal to patients seeking more convenient treatment options compared to traditional injectables [1][2][5]