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    Home > Medical News > Latest Medical News > IL-23 inhibitor Tremfya has been recommended by the European Union CHMP approval domestic market!

    IL-23 inhibitor Tremfya has been recommended by the European Union CHMP approval domestic market!

    • Last Update: 2020-11-06
    • Source: Internet
    • Author: User
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    Johnson and Johnson's Janssen Pharmaceuticals recently announced that the European Medicines Agency (EMA) Commission on Human Pharmaceutical Products (CHMP) has issued an active review recommending approval of Tremfya's expanded use for the treatment of active psoriasis arthritis (PsA) adult patients suitable for system therapy.
    in the European Union, Tremfya was first approved in November 2017 to treat adult patients with moderate to severe plaque psoriasis suitable for systemic therapy.
    Tremfya is a monoclonal antibody that selectively binds to p19 sub-base of leukocyte mesokine-23 (IL-23) and inhibits its interaction with IL-23 receptors.
    IL-23 is a naturally occurring cytokine and an important driver of the pathogenesis of inflammatory diseases such as psoriasis and PSA.
    PSA is a chronic inflammatory disease characterized by joint pain and skin inflammation.
    clinical studies have shown that Tremfya significantly improves the joints, skin, soft tissue symptoms and signs of active PSA patients compared to placebos.
    the United States, Tremfya was the first IL-23 selective inhibitor approved for the treatment of active PSA, and prescription information indicates that the use of FACIT-F evaluation can improve patient fatigue symptoms.
    the use of drugs, Tremfya is injected under the skin at a dose of 100 mg, once in weeks 0 and 4, and every 8 weeks therein.
    tremfya can be used alone or in combination with traditional disease-modified anti-rheumate drugs such as methotrexate.
    review of CHMP, based on data from 2 Phase III clinical studies (DISCOVER-1 and DISCOVER-2).
    two studies evaluated Tremfya's efficacy and safety relative to placebos.
    , the DISCOVER-1 study included patients who had not previously received biotherapy (the initial treatment of biotherapy) or had been treated with anti-tumor necrosis factor α (TNF alpha) biologics.
    the DISCOVER-2 study, which included only first-time patients with biotherapy, also assessed radiological advances in joint damage.
    In two studies, patients were randomly assigned to receive Tremfya 100mg every 4 weeks or every 8 weeks for 52 weeks, and patients receiving a placebo were moved to Tremfya in the 24th week of treatment until week 52.
    24-week results from two studies were published in April in The Lancet, the world's top medical journal.
    results showed that both studies reached the primary endpoint: at 24 weeks of treatment, a significantly higher percentage of patients in the Tremfya treatment group improved their symptoms and symptoms by at least 20 percent (ACR20 remission) compared to the placebo group.
    , the Tremfya group had 52 percent, 64 percent and placebo groups 22 percent and 33 percent, respectively, in two studies.
    In addition, in two studies, the Tremfya treatment group showed significant improvements in multiple secondary endpoints (joint symptoms, skin symptoms, soft tissue inflammation and disease activity, physical function, and health-related quality of life) compared to the placebo group.
    also improved the patient's fatigue symptoms through the Chronic Disease Treatment Function Assessment-Fatigue Scale (FACIT-F).
    overall safety observed in PSA patients was generally consistent with that of plaque-type psoriasis patients, accompanied by a decrease in bronchitis and neutral granulocyte counts.
    Tremfya is a human monoantigen resistant to lyeline 23 (IL-23) p19 subi, the drug being the first approved selective IL-23 inhibitor.
    IL-23 is a cytokine that plays a key role in a variety of autoimmune diseases.
    currently, Tremfya is also developing treatments for other autoimmune diseases, including Crohn's disease (IIb/III), ulcerative colitis (IIb/III), and purulent sweat adenitis (Phase II).
    , Tremfya has been approved in many countries and regions around the world for the treatment of adult patients with moderate to severe plaque psoriasis.
    in China, Tremfya was approved for listing in Hong Kong in November 2018, declared public on the mainland in late June 2019 and approved by china's State Drug Administration (NMPA) in December 2019 for the treatment of adult patients with moderate to severe plaque psoriasis suitable for systemic treatment.
    It is worth mentioning that Tremfya has been included in the "First List of Clinically UrgentLy Needed Foreign New Drugs" issued by the NMPA Drug Review Center (CDE), which treats adaptations such as red-skin psoriasis, plaque-type psoriasis, pustules-type psoriasis, psoriasis arthritis, and common psoriasis.
    NMPA has accelerated its approval of Tremfya's listing in accordance with the priority review approval process.
    references: . Jun Zhu; Zhen Liang; Yuxuan Song; Yongjiao Yang; Yawei Xu; Yi Lu; Rui Hu; Ningjing Ou; Wei Zhang; Xiaoqiang Liu.Can the group of biparametric magnetic resonance imaging and PSA-indicators relateds predict the prostate biopsy outcome. (J). Andrologia.2020 .B. Chakraborty; R. Saha; S. Chattopadhyay; D. De; R.D. Das; M.K. Mukhopadhyay; M. Palit; C. Roy Chaudhuri.Impact of surface defects in electron beaming means of ZnO thin films on FET biosensing characters towards reliable PSA detection. (J). Applied Surface Science.2020. Nana Qi; Yang Chen; Yanyu Zeng; Mengying Bao; Xinyang Long; Yajie Guo; Aihua Tan; Yong Gao; Haiing Zhang; Xiaobo Yang; Yanling Hu; Zengnan Mo; Yonghua Jiang.rs2274911 polymorphism in GPRC6A associated with serum E2 and PSA in a Southern Chinese male population. (J). Gene.2020
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