JNJ Seeks EU Approval for Oral Psoriasis Drug Icotrokinra

Core Insights - Johnson & Johnson (JNJ) has submitted a regulatory filing to the European Medicines Agency (EMA) for icotrokinra, an investigational oral peptide aimed at treating moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 and above [1][7] - The filing is supported by data from four phase III studies, which demonstrated significant skin clearance and a favorable safety profile with once-daily oral dosing [2][3] Regulatory Filing and Clinical Trials - The EMA filing is based on results from the ICONIC clinical development program, which includes studies ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2 [2] - All four studies met their primary and co-primary endpoints, confirming the efficacy and safety of icotrokinra [3][7] Market Performance - Year to date, JNJ shares have increased by 23.5%, contrasting with a 0.4% decline in the industry [4] Development and Collaboration - Icotrokinra is being developed in collaboration with Protagonist Therapeutics, with JNJ holding exclusive worldwide rights for development beyond phase II studies [5] - The management believes icotrokinra has the potential to redefine the treatment landscape for plaque psoriasis [5] Broader Applications - In addition to plaque psoriasis, icotrokinra is being explored for other IL-23-mediated diseases, such as psoriatic arthritis and ulcerative colitis [8] - Positive results were reported from the phase IIb ANTHEM-UC study for ulcerative colitis, meeting its primary endpoint across all dose groups [8] Mechanism of Action - Icotrokinra is designed to block the IL-23 receptor, which is a key driver of inflammation in plaque psoriasis, indicating potential for use in other IL-23-driven diseases [9] Company Ranking - JNJ currently holds a Zacks Rank 2 (Buy), indicating a favorable outlook in the market [10]