J&J(US:JNJ) The Manila Timesยท2025-09-11 12:07Core Insights - Johnson & Johnson has submitted an application to the European Medicines Agency (EMA) for icotrokinra, a first-in-class investigational oral peptide targeting the IL-23 receptor for treating moderate-to-severe plaque psoriasis in patients aged 12 and older [1][2][4]. Group 1: Clinical Development and Efficacy - The application is based on data from four Phase 3 studies, including ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2, which met all primary and co-primary endpoints [1][6][8]. - Icotrokinra demonstrated significant skin clearance and a favorable safety profile, achieving co-primary endpoints of Investigator's Global Assessment (IGA) score of 0/1 and Psoriasis Area and Severity Index (PASI) 90 compared to placebo [6][7][13]. - The ICONIC-ADVANCE studies showed superiority of icotrokinra over deucravacitinib in patients with moderate-to-severe psoriasis [1][6][13]. Group 2: Safety Profile - Pooled safety data indicated that 49.1% of patients treated with icotrokinra experienced adverse events, compared to 51.9% in the placebo group, with no new safety signals identified [1][6][8]. - The safety profile of icotrokinra is considered favorable relative to comparators, supporting its potential as a treatment option [2][4]. Group 3: Future Studies and Research - Johnson & Johnson has initiated the Phase 3 ICONIC-ASCEND study, which aims to demonstrate the superiority of icotrokinra compared to the injectable biologic ustekinumab and placebo [4][10]. - Long-term data from the ICONIC development program, including at least 52 weeks of treatment, is being prepared for future presentations [6][8]. Group 4: Market Context - Plaque psoriasis affects approximately 6.4 million people in Europe and over 125 million globally, with nearly one-quarter of cases classified as moderate-to-severe [9][10]. - The burden of plaque psoriasis extends beyond physical symptoms, impacting emotional health and quality of life [9][10].