Johnson & Johnson (J&J) announced on 21 July its submission of a new drug application (NDA) in its US homeland for icotrokinra, a first-in-class oral peptide targeting the interleukin-23 (IL-23) receptor for moderate-to-severe plaque psoriasis. The filing is supported by data from four Phase III trials (ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1 and 2) showing superior skin clearance versus placebo and deucravacitinib, with 49.1% adverse event rates matching placebo. Key endpoints included 90% psoriasis area severity index (PASI 90) and investigator global assessment (IGA) scores of 0/1 at week 16.

Icotrokinra demonstrated efficacy in difficult-to-treat areas like scalp/genital psoriasis and maintained safety over 52+ weeks. J&J is also conducting the Phase III ICONIC-ASCEND trial, the first head-to-head study comparing an oral therapy (icotrokinra) to injectable biologic ustekinumab. The drug's selective IL-23R blockade offers potential in ulcerative colitis and psoriatic arthritis, with global rights held under a 2017 Protagonist Therapeutics collaboration.

According to PharmCube's NextBiopharm® database, there is a total of 12 plaque psoriasis candidate therapies currently under review globally. Click here to request a free trial for NextBiopharm®.

Source:
https://www.jnj.com/media-center/press-releases/johnson-johnson-seeks-first-icotrokinra-u-s-fda-approval-aiming-to-revolutionize-treatment-paradigm-for-adults-and-adolescents-with-plaque-psoriasis