Two First-in-Class New Drugs Filed for Approval on the Same Day: J&J’s Oral IL-23R Antagonist Icotrokinra and BMS’s TYK2 Inhibitor Deucravacitinib

On July 21 local time, two companies announced the submission of their new drug applications for market approval, namely 1) Johnson & Johnson's oral IL23R antagonist.Icotrokinra Submits New Drug Application in the U.S. for the Treatment ofAdults and children aged 12 years and aboveModerate to Severe Plaque Psoriasis; 2) BMS TYK2 InhibitorDeucravacitinibTreatmentActive Psoriatic ArthritisThe new indication application has been accepted by the FDA.PDUFA Date: March 6, 2026。*For more information in 2025, pleaseNew Drug Application for Market LaunchIntelligence,Scan the QR code at the end of the article to add Xiaoyin and download for free.

   Icotrokinra 

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

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

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。

Deucravacitinib（Deucravacitinib）It is a tyrosine kinase 2（TYK2）Inhibitor,By selectively targeting TYK2 to inhibit the signaling of IL-23, IL-12, and IFN, these cytokines are key players in the pathogenesis of various immune-mediated diseases.

DeucravacitinibAchieved by binding to the regulatory domain of TYK2Highly Selective, leading to the allosteric inhibition of TYK2 and its downstream functions. Within the physiological concentration range, this productSelective inhibition of TYK2 at therapeutic dosesDoes not inhibit JAK1, JAK2, or JAK3.

September 2022,Deucravacitinib Approved for Marketing in the U.S. for Adult Plaque Psoriasis, BecomingThe World's FirstApproved TYK-2 Allosteric Inhibitor. October 2023,Deucravacitinib inFirst approved for marketing 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 of the pivotal trials POETYK PsA-1 and POETYK PsA-2, which evaluatedDeucravacitinibCorrectActive Psoriatic ArthritisEfficacy and safety in adult patients.

Both trials met the primary endpoint, with those receivingDeucravacitinibPatients treated after 16 weeks of treatmentAchieve ACR20 Relief(Improvement of disease signs and symptoms by at least 20%)The proportion is significantly higher.POETYK PsA-2 Study Data Reports 52-Week Treatment Outcomes, Indicating Clinical Remission from Week 16 to Week 52Improved and Maintained。

Insight database shows that, except forPlaque Psoriasis andActive psoriatic arthritis,Deucravacitinib is also being developed forSjögren's Syndrome(Phase III Clinical Trial)、Systemic Lupus Erythematosus(Clinical Phase III), Crohn's Disease(Phase II Clinical)And other indications.

Cover image source: ZCOOL HELLOR

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