Diabetes Prevention Provention Bio filed a rolling listing application for Teplizumab with the FDA

In August 2019, the FDA awarded Teplizumab Breakthrough Therapy (BTD) for preventing or delaying the on-impact development of type 1 diabetes.
clinical trial results, published in the New England Journal of Medicine at the time, showed that teplizumab could delay the onset of type 1 diabetes by two years or more.
As a chronic autoimmune disease, the immune system of people with type 1 diabetes mistakenly attacks their islet β cells, causing the β cells to gradually impair and die, and eventually the patient needs to rely on external insulin for treatment.
For people with type 1 diabetes genetic susceptible, the disease has begun to develop before significant hyperglycemia symptoms occur, mainly due to the appearance of autoantibodies (anti-insulin and anti-pancreatic antibodies, etc.) and abnormal glucose tolerance.
this time, β cells in the pancreas remain largely intact, providing a vital window β to intervene and preserve these cells.
, there is a lack of ways to prevent the onset of type 1 diabetes in high-risk groups.
Teplizumab is a monoclonal antibody (mAb) that targets CD3 antigens on the surface of T cells and is being developed to prevent or delay the on-form of type 1 diabetes.
more than 800 patients have been treated with teplizumab in a number of clinical studies in which more than 1,000 subjects were included.
previous studies of newly diagnosed patients, teplizumab has consistently demonstrated the ability to retain β cellular function and has accordingly reduced the need for external insulin use.
Teplizumab has been recognized by the FDA as a breakthrough therapy and by the European Medicines Agency's PRIME.
references: s1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Retrieved 2020-11-02, from Source: Supplied