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    Home > Active Ingredient News > Endocrine System > Rapidly delaying the progression of type 1 diabetes, innovative immunotherapy enters the FDA review stage

    Rapidly delaying the progression of type 1 diabetes, innovative immunotherapy enters the FDA review stage

    • Last Update: 2022-04-30
    • Source: Internet
    • Author: User
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    ▎WuXi AppTec content team editors Today, Provention Bio announced that the U.
    S.
    FDA has accepted the company’s resubmitted Biologics License Application (BLA) for its investigational therapy teplizumab to delay clinical type 1 diabetes in at-risk groups occurrence
    .

    The FDA has previously granted it breakthrough therapy designation
    .

    If approved, it would be the first therapy to change the course of type 1 diabetes, the release notes
    .

    The immune system of patients with type 1 diabetes will mistakenly attack their own islet beta cells, resulting in progressive impairment and death of beta cell function, and eventually patients need to rely on exogenous insulin for treatment
    .

    For people with genetic susceptibility to type 1 diabetes, the disease has begun to develop before obvious symptoms of hyperglycemia, mainly manifested as the appearance of autoantibodies (anti-insulin and anti-pancreatic antibodies, etc.
    ) and abnormal glucose tolerance
    .

    During this time, beta cells in the pancreas remain largely intact, providing a crucial window for intervention and preservation of beta cells
    .

    Currently, there is a lack of methods to prevent the onset of type 1 diabetes in high-risk groups
    .

    Teplizumab is a monoclonal antibody targeting the CD3 antigen on the surface of T cells.
    Its Fc region is modified with amino acids to reduce the binding to complement and Fc receptors, reducing its potential toxicity
    .

    Teplizumab attenuates the autoimmune attack on pancreatic beta cells, thereby protecting beta cells from destruction, thereby preventing or delaying the onset of type 1 diabetes
    .

    It was granted Breakthrough Therapy Designation by the FDA in 2019 to prevent or delay the onset of type 1 diabetes
    .

    ▲ The potential working mechanism of Teplizumab (Image source: Reference [2]) The results of a study published in Science Translational Medicine last year showed that in high-risk patients treated with teplizumab, there was no clinical manifestation at a median follow-up time of 2.
    5 years.
    The proportion of patients with type 1 diabetes reached 50%, more than double that of the placebo group (22%) (HR=0.
    457, p=0.
    01)
    .

    In addition, studies have shown that teplizumab treatment significantly improves islet beta cell function, as well as insulin secretion capacity
    .

    Last May, the FDA's Endocrine and Metabolic Drugs Advisory Committee (EMDAC) voted 10:7 to support the benefits of teplizumab in patients with type 1 diabetes (T1D) that outweigh the risks
    .

    However, in July last year, the US FDA gave a CRL to the application for teplizumab
    .

    In February of this year, Provention Bio resubmitted the BLA to respond to the questions raised in the CRL
    .

    "We are pleased that the FDA accepted our BLA resubmission as a complete response to obtaining a CRL in 2021, " said Mr.
    Ashleigh Palmer, co-founder and CEO of Provention Bio
    .

    An important step towards delivering the first disease course-altering therapy
    .

    "Reference: [1] Provention Bio Announces FDA Acceptance of the Biologics License Application (BLA) Resubmission for Teplizumab for the Delay of Clinical Type 1 Diabetes in At-Risk Individuals.
    Retrieved March 21, 2022, from https://www.
    prnewswire.
    com/news-releases/provention-bio-announces-fda-acceptance-of-the-biologics-license-application-bla--resubmission-for-teplizumab-for-the-delay-of-clinical-type-1 -diabetes-in-at-risk-individuals-301506191.
    html[2] Teplizumab Overview.
    Retrieved Aug 5, 2019, from https:// Disclaimer: WuXi AppTec Content Team Focus on introducing the progress of global biomedical health research
    .

    This article is for the purpose of information exchange only.
    The opinions in this article do not represent WuXi AppTec's position, nor do they support or oppose the opinions in the article
    .

    This article is not a treatment plan recommendation
    .

    If you need to obtain a treatment plan For guidance, please go to a regular hospital for treatment
    .

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