Overview
- The approval covers moderate to severe plaque psoriasis in adults and adolescents 12 years and older who weigh at least 40 kg.
- Icotyde is the first targeted oral peptide to block the IL-23 receptor, offering an alternative to injectable IL-23 biologics.
- Four phase 3 studies in about 2,500 patients supported approval, with head-to-head data showing superior skin clearance versus Sotyktu and about 55% achieving PASI-90 at week 16.
- Safety results showed adverse event rates close to placebo and no new signals through 52 weeks in the clinical program.
- J&J developed Icotyde with Protagonist Therapeutics, is pursuing additional indications such as ulcerative colitis, psoriatic arthritis and Crohn’s disease, and competitor stocks like AbbVie fell roughly 4% to 5% after the decision as pricing details remain undisclosed.