Johnson & Johnson Submits NDA for Oral IL-23R Antagonist Icotrokinra; BMS Files sNDA for Deucravacitinib in Psoriatic Arthritis

On July 21 local time, two companies announced the submission of their new drug applications for market approval, respectively:

1）Johnson & Johnson Submits New Drug Application in the U.S. for Oral IL23R Antagonist Icotrokinra to Treat Adults and Children Aged 12 Years and AboveModerate to Severe Plaque Psoriasis；

2）BMS TYK2 Inhibitor Deucravacitinib TreatmentActive Psoriatic ArthritisThe new indication application has been accepted by the FDA,PDUFA Date: March 6, 2026。

Johnson & JohnsonIcotrokinra: PotentialBICOral IL-23R Antagonist

Icotrokinra is a product developed by Johnson & Johnson.Nearly US$1 billion for the oral IL-23R antagonist with BIC potential introduced from Protagonist is currentlyThe world's first and onlyReport to the marketIL-23R Targeted Drugs.Johnson & Johnson has high hopes for Icotrokinra, with projected peak annual sales expected to reachMore than 50 billion US dollars。

This marketing application includes data from four pivotal Phase III studies, including ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, in adult and pediatric patients aged 12 years and older with moderate to severe plaque psoriasis.IcotrokinraThe treatment achieved all primary endpoints and co-primary endpoints of the entire development program, demonstratingOnce DailyThe oral tablet has a significant rate of skin lesion clearance and good safety.

Results from the ICONIC-ADVANCE 1 and 2 studies show,IcotrokinraAchieved the co-primary endpoints and demonstrated superior efficacy to deucravacitinib in moderate to severe plaque psoriasis.。

In all studies, the pooled safety data show,IcotrokinraThe proportion of patients experiencing adverse events (AE) was similar between the treatment group (49.1%) and the placebo group (51.9%), with no new safety signals identified.

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

Deucravacitinib:The World's First Approved TYK-2 Allosteric Inhibitor

BMS's Deucravacitinib is a tyrosine kinase 2 (TYK2) inhibitor that selectively targets TYK2 to inhibit the signaling of IL-23, IL-12, and IFN, all of which are key cytokines involved in the pathogenesis of various immune-mediated diseases.

Deucravacitinib achieves its effect by binding to the regulatory domain of TYK2.Highly Selective, leading to the allosteric inhibition of TYK2 and its downstream functions. Within the physiological concentration range, this product selectively inhibits TYK2 without suppressing JAK1, JAK2, or JAK3 at therapeutic doses.

In September 2022, Deucravacitinib was approved for marketing in the United States for adult plaque psoriasis, becomingThe World's FirstApproved TYK-2 Allosteric Inhibitor. In October 2023, Deucravacitinib was approved for the first time in China for the treatment ofAdult patients with moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy. In 2024, the global sales of the drug reached$246 million, a significant increase of 44.71% year-on-year.

This regulatory submission is based on the positive results from the pivotal trials POETYK PsA-1 and POETYK PsA-2, which evaluated deucravacitinib forActive Psoriatic ArthritisEfficacy and safety in adult patients.

Both trials met their primary endpoints, with patients receiving deucravacitinib showing improvement at 16 weeks compared to the placebo group.Achieve ACR20 relief(Improvement of disease signs and symptoms by at least 20%)The proportion is significantly higher.The study data of POETYK PsA-2 reported the results of 52 weeks of treatment, indicating that clinical remission occurred between Week 16 and Week 52.Improved and maintained。

Insight database shows that, besides plaque psoriasis and active psoriatic arthritis, deucravacitinib is also being developed forSjögren's Syndrome(Clinical Phase III)、Systemic Lupus Erythematosus(Phase III Clinical Trial), Crohn's Disease(Phase II Clinical Trials) and other indications.

Source: Insight Database

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