Johnson & Johnson Announces FDA Approval of Icotyde (Icotrokinra), the First Oral IL-23 Receptor Antagonist for Moderate-to-Severe Plaque Psoriasis

Johnson & Johnson announced today that the U.S. FDA has approved the oral polypeptide therapy Icotyde (icotrokinra) for the first-line treatment of adult patients with moderate to severe plaque psoriasis (PsO), as well as pediatric patients aged 12 years and older, weighing at least 40 kg, and suitable for systemic therapy or phototherapy.According to the press release, Icotyde is the first targeted oral peptide drug capable of precisely blocking the IL-23 receptor.

Plaque psoriasis is an immune-mediated disease that can lead to excessive production of skin cells, resulting in inflamed, scaly plaques that may be itchy or painful.It is estimated that more than 125 million people worldwide suffer from the disease, and nearly a quarter of plaque psoriasis patients fall into the moderate to severe category.Plaque psoriasis not only affects physical health but also becomes a source of stress for emotional well-being, interpersonal relationships, and daily life, especially when lesions appear on visible or sensitive areas, significantly impacting the patient's physical comfort and quality of life. For many patients with moderate to severe conditions, targeted systemic treatment is crucial. This aligns with the recommendations of the International Psoriasis Council, which advises considering systemic treatment if significant improvement is not achieved after two consecutive cycles (each cycle lasting 4 weeks) of topical medication.

This approval is based on the evidence accumulated from the ICONIC clinical development program, which conducted evaluations in both adult and adolescent populations, covering psoriasis on high-impact areas such as the scalp and genitals. It also included multiple head-to-head comparative trials with active control drugs.In four Phase 3 clinical studies covering approximately 2,500 patients, Icotyde met all primary efficacy endpoints., and demonstrated good safety characteristics. In the superiority head-to-head studyApproximately 70% of patients achieved clear or almost clear skin (IGA 0/1) by week 16, and 55% of patients reached a Psoriasis Area and Severity Index (PASI) 90 response.By Week 16, the incidence of adverse reactions in the Icotyde treatment group was within 1.1% compared to the placebo group, and no new safety signals were identified by Week 52.

IcotydeIt is a "first-in-class" targeted oral peptide capable of selectively blocking the IL-23 receptor (IL-23R).IL-23 plays a key role in the pathogenic T-cell activation in moderate to severe plaque PsO and is fundamental to inflammatory responses in PsO, other dermatological conditions, rheumatic diseases, and IL-23-mediated gastrointestinal disorders. Icotyde binds to IL-23R with single-digit picomolar affinity and potently inhibits IL-23 signaling in human T cells with high selectivity.

In the field of psoriasis, this February,Novartis SecukinumabApproved for a new indication in China, used for treating moderate to severe plaque psoriasis in children. In addition, there are multiple IL-23 targeted drugs under research and already on the market, includingInnovent Biologics' approved Picankibart and Johnson & Johnson's Guselkumabetc.

Reference: WuXi AppTec

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