FDA Approves ICOTYDE (Icotrokinra) for Plaque Psoriasis

In a new press release, Johnson & Johnson reports that the FDA has approved ICOTYDE (icotrokinra) for moderate-to-severe plaque psoriasis in adults and in pediatric patients aged 12 years and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy.

The FDA decision was based on the Phase 3 ICONIC clinical development program, which included five phase 3 studies. Four Phase 3 studies totaling about 2,500 patients met primary efficacy endpoints. Superiority studies showed Week 16 response rates of approximately 70% for clear or almost clear skin on the Investigator’s Global Assessment (IGA 0/1) and 55% for a Psoriasis Area and Severity Index (PASI) 90 response.

Adverse reaction rates among ICOTYDE-treated patients were within 1.1% of placebo through Week 16. No new safety signals were identified through Week 52.

ICOTYDE is a targeted oral peptide designed to precisely block the IL-23 receptor. It binds the receptor with high affinity and has demonstrated inhibition of IL-23 signaling in human T cells.