The FDA has approved Johnson & Johnson’s Icotyde (icotrokinra) as the first and only oral peptide to target the interleukin-23 receptor for the treatment of moderate-to-severe plaque psoriasis.
Icotyde is approved for adults and pediatric patients age 12 and older who weigh at least 40 kilograms and are candidates for systemic therapy or phototherapy, according to a March 18 news release. The once-daily oral medication introduces a novel mechanism in psoriasis care, previously dominated by injectable biologics.
Approval was based on four phase 3 trials involving 2,500 patients. At week 16, nearly 70% of Icotyde-treated patients achieved clear or almost clear skin, and 55% of patients’ psoriasis improved by at least 90%. Adverse events were within 1.1% of placebo through week 16, with no new safety signals observed through week 52.
Johnson & Johnson said Icotyde’s approval marks a shift in first-line systemic therapy for psoriasis, offering an alternative for patients cycling through topical regimens without lasting benefit. The company also launched a patient support program to facilitate access.
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