Johnson & Johnson Says FDA OKs ICOTYDE, First Oral IL-23 Receptor Antagonist For Plaque Psoriasis

Johnson & Johnson

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(RTTNews) - Johnson & Johnson (JNJ) announced Wednesday that the U.S. Food and Drug Administration (FDA) has approved ICOTYDE (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy.

ICOTYDE is the first and only targeted oral peptide that precisely blocks the IL-23 receptor. ICOTYDE met all primary efficacy endpoints and demonstrated a favorable safety profile across four Phase 3 studies including 2,500 patients.

The approval is based on an unprecedented body of evidence from the ICONIC clinical development program, which simultaneously evaluated ICOTYDE in adults and adolescents, high impact sites such as scalp and genital PsO, and in duplicate head-to-head trials versus an active comparator.

In the head-to-head superiority studies, approximately 70% of patients achieved clear or almost clear skin and 55% of patients achieved a Psoriasis Area and Severity Index (PASI) 90 response at Week 16.

The company said ICOTYDE delivers something unique in psoriasis treatment, combining skin clearance with a favorable safety profile in a once, daily pill, making it an easy addition to a patient's routine.