Johnson & Johnson Submits NDA in China for First-in-Class Oral IL-23R Antagonist Icotrokinra for Moderate-to-Severe Plaque Psoriasis

On November 19, the CDE website showed that Johnson & JohnsonClass 1 New DrugEcallantide Hydrochloride Tablets Submitted for Marketing ApprovalIndications for UseAdult patients with moderate to severe plaque psoriasis and pediatric patients aged 12 years and above who are suitable for systemic therapy or phototherapyOn the same day, the indication was also included in the proposed priority review by the CDE.

Screenshot source: CDE official website

Ecallantide Hydrochloride Tablets（Icotrokinra）It was Johnson & Johnson's investmentNearly 1 billion US dollarsFrom ProtAgonist IntroducedFirst-in-Class Oral Peptide Drug(IL-23R Antagonist). TodayIn July, the drug was submitted for marketing approval in the United States, and in September, it was submitted for marketing approval in Europe. It is worth mentioning that,ICotrokinra is currentlyThe world's first and onlyAn IL-23R-targeted drug reported for market launch. Johnson & Johnson has high hopes for this, with projected peak annual sales expected to reachMore than 50 billion US dollars。

Screenshot source: Company official website

ICONIC-ADVANCE 1 and 2 are randomized controlled Phase III clinical trials designed to evaluate ICotrokinra andDeucravacitinib(The world's first approved TYK-2 allosteric inhibitor）AndonCompared with placebo, the efficacy and safety in patients with moderate to severe plaque psoriasis. The co-primary endpoints are the subjects achieving PASI 90 (90% improvement in Psoriasis Area and Severity Index)AndIGA score is 0/1(Skin symptoms eliminated or nearly eliminated), and improve by at least 2 grades.

In these two studies,Icotrokinra achieved two co-primary endpoints at week 16 compared to placebo.The incidence of adverse events was similar. , and shows superiority at the time point.DeucravacitinibEfficacy and Safety.

• Compared with placebo(Week 16)AndDeucravacitinib(Week 16 and Week 24)In comparison,Icotrokinra Demonstrates Superior Skin Clearance Rate。
  

• Adverse Events of Icotrokinra (AE) The incidence rate was similar to that of the placebo, and no new safety signals were identified. As of Week 24,Week, the AE incidence rate of Icotrokinra was numerically lower thanDeucravacitinib。

In all studies, the pooled safety data show,Icotrokinra Group(49.1%)and placebo group (51.9%) Experience adverse events between (AE) The proportion of patients was similar, and no new safety signals were detected.

In addition,Johnson & Johnson has also launched the Phase III ICONIC-ASCEND study, the first trial designed to demonstrate the superiority of the oral drug Icotrokinra over injectable biologics.DoseHead-to-Head Study of Ustekinumab。

In terms of long-term data, in the ICONIC-LEAD study,Icotrokinra Demonstrates Sustained Skin Clearance and Favorable Safety Profile in Adult and Adolescent Patients at Week 52。

• At week 52, adult patients who achieved PASI 90 and were re-randomized to the icotrokinra group at week 24 had a higher PASI 90 maintenance rate compared to those re-randomized to the placebo group.（84% vs 21%；p<0.001）。
• At week 52, 86% of adolescents treated with icotrokinra for 52 weeks achieved PASI 90, while 77% of those who switched from placebo to icotrokinra at week 16 achieved PASI 90.

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Disclaimer:This article is for information sharing only,不代表 Insight 立场和观点, and does not recommend or introduce any treatment options. If you have any needs, please consult and contact正规医疗机构.

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