Johnson & Johnson's Oral Peptide Drug Icotrokinra Granted Priority Review in China for Moderate-to-Severe Plaque Psoriasis

The official website of the Center for Drug Evaluation (CDE) under China's National Medical Products Administration recently announced that a new Class 1 drug, icotrokinra, submitted by Johnson & Johnson has been proposed for priority review due to its "new type, formulation, and specifications of pediatric drugs tailored to children's physiological characteristics." It is applicable for treating patients suitable for systemic treatment or phototherapy.Adult patients with moderate to severe plaque psoriasis and pediatric patients aged 12 years and older。Public information shows that icotrokinra is a targeted oral peptide that can selectively block the interleukin-23 receptor (IL-23R).The ProductWas named one of the top ten star molecules of 2024 by the well-known industry media Drug Hunter earlier this year.

Psoriasis is a chronic inflammatory skin condition. Plaque psoriasis is the most common type, characterized by dry, raised patches on the skin covered with gray or silvery scales. While biologics are relatively effective, they are generally injectable formulations, and the efficacy of existing oral therapies still has limitations.

Icotrokinra is a novel oral targeted peptide that works by selectively blocking IL-23R. IL-23 plays a key role in the activation of pathogenic T cells in moderate to severe plaque psoriasis and is fundamental to inflammatory responses in psoriasis, other dermatological conditions, rheumatological diseases, and IL-23-mediated gastrointestinal disorders.Icotrokinra can bind to IL-23R with high affinity and exert potent selective inhibition of IL-23 signaling in human T cells.

In July this year, Johnson & Johnson and Protagonist Therapeutics submitted a New Drug Application (NDA) to the U.S. FDA, seeking approval for their jointly developed icotrokinra for the treatment of adult and pediatric patients aged 12 years and older with moderate to severe plaque psoriasis (PsO).

This November, The New England Journal of Medicine (NEJM) published the results of the Phase 3 clinical trial ICONIC-LEAD. This was a Phase 3, double-blind, randomized, placebo-controlled trial that enrolled a total of 684 patients aged 12 years and older with moderate to severe plaque psoriasis, who had ≥10% body surface area affected by psoriatic lesions, a Psoriasis Area and Severity Index (PASI) score of ≥12, and an Investigator's Global Assessment (IGA) score of ≥3.Patients were randomly assigned in a 2:1 ratio to receive either 200 mg of icotrokinra once daily or placebo, with the placebo group switching to icotrokinra after 16 weeks, for a total treatment duration of 24 weeks.

The research results show that,At 16 weeks of treatment, 65% of patients in the icotrokinra group achieved an IGA 0/1 response (IGA score of 0/1 and a reduction of ≥2 points from baseline), indicating complete or almost complete clearance of skin lesions, significantly higher than the 8% in the placebo group.Icotrokinra group 50% of patients achieved PASI 90 response (PASI score baseline decreased by more than 90%), while only 4% in the placebo group.

At Week 16, according to IGA assessment,In the icotrokinra group, 33% of patients achieved complete clearance of skin lesions (IGA 0), and according to PASI assessment, 27% had complete resolution of skin symptoms (PASI 100); both significantly better than the placebo group’s 1% and less than 1%, respectively.

In addition, icotrokinra takes effect rapidly,A significant improvement in PASI 75 response was observed by Week 4 of treatment (15% vs 2%), and a significant improvement in PASI 90 response was observed by Week 8 of treatment (21% vs 1%).The efficacy of the drug was maintained throughout the study period. By week 24, the response rates across all indicators continued to increase in patients treated with icotrokinra. In the adolescent subgroup, by week 16, a higher proportion of patients receiving icotrokinra achieved IGA 0/1 response (84% vs 27%) and a higher proportion achieved PASI 90 response (70% vs 14%).

The ICONIC-LEAD study is still ongoing, aiming to collect data over a period of up to 3 years, which will help provide a more comprehensive understanding of the benefit-risk ratio of icotrokinra.

This timeIcotrokinra is proposed to be included in the priority review in China, which is expected to accelerate the product's marketing approval process in China, bringing new treatment options to more psoriasis patients as soon as possible.

References:
[1] Official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Fromhttps://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2]Robert Bissonnette, et al., (2025). Oral Icotrokinra for Plaque Psoriasis in Adults and Adolescents. N Engl J Med, DOI: 10.1056/NEJMoa2504187

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