SPRING HOUSE, PA — Johnson & Johnson has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for icotrokinra, a once-daily oral peptide therapy targeting the interleukin‑23 (IL‑23) receptor. If approved, it would be the first oral IL‑23 receptor antagonist available for both adults and adolescents aged 12 and older with moderate to severe plaque psoriasis.
The submission is backed by results from four Phase 3 clinical trials—ICONIC‑LEAD, ICONIC‑TOTAL, ICONIC‑ADVANCE 1, and ICONIC‑ADVANCE 2. These studies showed that icotrokinra consistently met its primary and co-primary endpoints, delivering meaningful improvements in skin clearance and maintaining a favorable safety profile in both adult and adolescent populations.
In particular, the ADVANCE trials compared icotrokinra head-to-head with deucravacitinib, another oral therapy for psoriasis. Results favored icotrokinra, highlighting its potential to outperform current oral treatment options.
Trial data revealed that approximately 49% of patients receiving icotrokinra reported adverse events, compared to 52% in the placebo group. No new safety issues emerged, reinforcing confidence in the drug’s tolerability.
Key findings include:
- In the ICONIC‑LEAD trial, patients achieved significant improvements in the Investigator’s Global Assessment (IGA) and at least a 90% reduction in the Psoriasis Area and Severity Index (PASI 90) by Week 16.
- Adolescent participants in a subgroup analysis of the same trial showed similar efficacy results, marking an important milestone for younger patients living with the condition.
Johnson & Johnson describes icotrokinra as a first-in-class therapy—a targeted oral peptide that blocks the IL‑23 receptor, a key driver of inflammation in plaque psoriasis. The company believes this innovation could reshape the treatment landscape by offering an alternative to injectables, with the convenience of a once-daily pill.
If granted FDA approval, icotrokinra will become the first oral treatment in its class, expanding therapeutic options for patients and potentially setting a new standard in psoriasis care.
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