Summary
Johnson & Johnson and Protagonist Therapeutics received U.S. FDA approval for ICOTYDE (icotrokinra), the first targeted oral IL-23 receptor peptide therapy for moderate-to-severe plaque psoriasis in adults and adolescents (12+ years, ≥40 kg).
Once-daily 200 mg oral tablet blocks IL-23 signaling with high affinity; taken on an empty stomach before food for biologic-like efficacy without injections.
Four pivotal trials (2,500 patients) showed ~70% achieving clear/almost clear skin (IGA 0/1) and 55% PASI 90 at Week 16; superior to SOTYKTU; safety similar to placebo (1.1% difference at Week 16, no new signals at Week 52).
Johnson & Johnson an...
