Overview
- The FDA approved once-daily Icotyde for moderate-to-severe plaque psoriasis in adults and adolescents 12 years or older who weigh at least 40 kg.
- Icotyde is the first targeted oral peptide to block the IL-23 receptor, providing an alternative to injectable IL-23 inhibitors such as Skyrizi and Tremfya.
- The approval is supported by four Phase 3 trials of about 2,500 patients showing roughly 70% IGA clear or almost clear and about 55% PASI-90 at week 16, a safety profile similar to placebo through 52 weeks, and superiority to Sotyktu in head-to-head studies.
- AbbVie shares fell roughly 4%–5% after the news as investors assessed competition to Skyrizi, and J&J projects multibillion-dollar peak sales potential for Icotyde.
- Approval triggers a $50 million milestone payment to Protagonist Therapeutics, and J&J is running additional studies in psoriatic arthritis, ulcerative colitis and Crohn’s disease.