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    Home > Medical News > Latest Medical News > AstraZenewer/Amway's potential "first-in-class" new drug application in China has been accepted.

    AstraZenewer/Amway's potential "first-in-class" new drug application in China has been accepted.

    • Last Update: 2020-10-17
    • Source: Internet
    • Author: User
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    Screenshot Source: CDE.com Tezepelumab is a thymus-based lymphocyte production (TSLP) inhibitor developed jointly by Amgen and AstraZeneca.
    is a potential "first-in-class" drug, according to amsin.
    TSLP is an upper-level regulator of multiple inflammatory pathways in a variety of diseases, including asthma, which is essential for the occurrence and ongoing of airway inflammation.
    studies have shown that TSLP is active in regulating T2 immunity.
    , it can also play a role in non-T2-driven inflammation by activating or signaling multiple types of cells, such as fat cells and alkaline granulocytes.
    , TSLP is considered a potential target for treating a wide range of asthmatic populations.
    blocking TSLP can prevent immune cells from releasing inflammatory cytokines, thereby preventing asthma from worsening and improving asthma control.
    in China, as well as AstraZeneca first submitted a clinical trial application for tezepelumab in early 2018 and was accepted by CDE, according to CDE's official website.
    this is the second time the product has submitted a clinical trial application in China.
    According to the China Drug Clinical Trial Registration and Information Disclosure Platform, tezepelumab is currently conducting two clinical trials in China, namely: Evaluation of the effectiveness and safety of tezepelumab in subjects with severe asthma control, International Multi-Center Phase 3 Clinical Trials;
    , according to a Phase 2b clinical trial called PATHWAY, three different doses of tezepelumab were used as an add-on therapy to treat asthma patients with a history of deterioration.
    results showed that low, medium and high doses of tezepelumab significantly reduced the annual rate of asthma deterioration in a wide range of patient groups.
    61 per cent (70 mg/every 4 weeks), 71 per cent (210 mg/every 4 weeks) and 66 per cent (280 mg/every 2 weeks) compared to the placebo group.
    , all three dose groups showed improved lung function and improved asthma control in patients at two higher doses.
    in terms of safety, the rates of adverse events were similar between the tezepelumab group and the placebo group.
    the positive results of the trial, the FDA awarded tezepelumab breakthrough therapies for the treatment of severe asthma patients.
    an earlier press release from AstraZeneta, Dr. Jonathan Corren, lead researcher on the PATHWAY trial, said the results confirmed the hypothesis that TSLP is an important medium for inflammation in severe asthma.
    due to the early activity of TSLP in inflammatory cascading reactions, tezepelumab can be applied to a large group of severe, uncontrolled asthma patients without considering the patient's ideopathic or T2 inflammatory biomarker status.
    Be aware that about two-thirds of people with severe asthma have type 2 (T2) inflammation-driven asthma, including eosinophil ideotypes, while currently available biotherapy is only available for T2-driven inflammatory patients.
    test results from Tezepelumab show the prospect of treating a wider group of people with severe asthma as a new treatment option.
    , Phase 3 clinical trials to test patients with severe asthma with uncontrolled symptoms of tezepelumab have been completed and results are expected in the second half of 2020.
    in addition to treating severe asthma, tezepelumab is also used in Phase 2 clinical trials to treat patients with endexual dermatitis and chronic obstructive pulmonary disease (COPD), according to AstraZeneca's official website.
    is a chronic airway inflammatory disease with a long course and recurrent onset.
    patients are usually shown to be wheezing, shortness of breath, chest tightness, cough and other symptoms, with the extension of the course of the disease can produce irreversible narrowing of the air channel and gastric remodeling.
    statistics, there are more than 300 million asthma patients worldwide.
    10 percent of these patients have severe asthma, and these patients have difficulty controlling their symptoms even with high doses of standard asthma control drugs, and may need to take oral corticosteroids (OCS) for long periods of time.
    severe, uncontrollable asthma causes weakness, worsening recurrent asthma, and severely restricted lung function.
    , patients urgently need safe and effective new therapies to improve their condition.
    : s1. CDE. Retrieved Oct 14, 2020, from . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Retrieved September 7, 2018, from Source: Medical Mission Hills.
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