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    Home > Active Ingredient News > Immunology News > Express | Topical JAK inhibitors to treat eczema, Incyte uses priority review coupons to submit new drug applications

    Express | Topical JAK inhibitors to treat eczema, Incyte uses priority review coupons to submit new drug applications

    • Last Update: 2021-03-25
    • Source: Internet
    • Author: User
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    ▎Incyte, editor of WuXi AppTec's content team, announced today that the US FDA has accepted the New Drug Application (NDA) for ruxolitinib cream and will give it priority review.

    Rucotinib cream is a selective JAK1/JAK2 inhibitor for topical application, used to treat atopic dermatitis (AD), which is a type of eczema.

    Atopic dermatitis is a serious chronic and recurrent skin disease.

    The main symptoms are itching, dry skin, and inflammation, which can appear on any part of the body.

    The symptoms of moderate to severe atopic dermatitis are severe itching, causing visible damage to the skin.

    Like other chronic inflammatory diseases, atopic dermatitis is mediated by the immune system and is related to the complex interaction between immune cells and inflammatory cytokines.

    Rucotinib Cream is a proprietary external formulation of JAK1/JAK2 selective inhibitor Rucotinib.

    JAKs belong to the family of cytoplasmic tyrosine kinases, and their function is to transduce signals mediated by cytokines (such as interferon).

    It can regulate the activity of inflammatory factors associated with the pathology of atopic dermatitis, and may directly regulate pruritus.

    ▲The association between atopic dermatitis and JAK signaling pathway (picture source: reference [2]) This application is based on a clinical development project called TRuE-AD, including two randomized double-blind, control with excipients Phase 3 clinical trials.

    The primary endpoint of the trial is the proportion of subjects who reach the investigator’s overall assessment of treatment success (IGA-TS), defined as the IGA score of 0 (skin symptoms are completely cleared) or 1 (skin symptoms are almost completely cleared at the 8th week of treatment ) And improve at least 2 points from the baseline.

    The results of the test showed that in two phase 3 clinical trials, the proportion of patients who received different doses of Rucotinib cream after receiving treatment for 8 weeks, achieved IGA-TS was significantly better than the control group.

    ▲The primary endpoint results of Lucotinib cream in two phase 3 clinical trials (picture source: reference [2]) Incyte used a priority review voucher to submit this NDA, which shortened the review time by 4 In December, the FDA is expected to respond before June 21 this year.

    Note: This article is intended to introduce medical and health research, not to recommend treatment options.

    If you need guidance on treatment plans, please go to a regular hospital for treatment.

    Reference: [1] Incyte Announces Acceptance and Priority Review of NDA for Ruxolitinib Cream for Atopic Dermatitis.
    Retrieved February 19, 2021, from https:// Ruxolitinib Cream : Phase 3 Data in Atopic Dermatitis.
    Retrieved February 19, 2021, from https://s21.
    q4cdn.
    com/114423841/files/doc_presentations/corporate/TRuE_AD_IR_webcast_April_6_2020_vFinal.
    pdf
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