First-ever oral IL-23 blocker ICOTYDE wins FDA approval for plaque psoriasis
TL;DR Summary
The FDA approved ICOTYDE (icotrokinra), the first oral peptide that selectively blocks the IL-23 receptor, for adults and adolescents 12+ weighing at least 40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In Phase 3 ICONIC trials, about 70% achieved IGA 0/1 and 55% reached PASI-90 by Week 16, with adverse events similar to placebo through Week 16 and no new safety signals through Week 52, suggesting a convenient once-daily option that could shift systemic treatment patterns. Johnson & Johnson notes patient support via ICOTYDE withMe and collaboration with Protagonist Therapeutics.
- FDA approval of ICOTYDE™ (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide Johnson & Johnson
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- FDA Approves Icotrokinra as First Targeted Oral Peptide for Moderate-to-Severe Plaque Psoriasis Pharmacy Times
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