FDA grants Provention Bio teplizumab (PRV-031) to prevent or delay type 1 diabetes

The immune system of a type 1 diabetes patient mistakenly attacks their own islet beta cells, causing gradual damage to beta cell function and death, and ultimately the patient will need to rely on exogenous insulin for treatmentToday,(http://) of The
of TheFDA(http://granted its non-Fc receptor-binding CD3 monoantigen in research therapy teplizumab (PRV-031) breakthrough therapy to prevent or delay the onset of type 1 diabetesAbout TeplizumabTeplizumab is a monoantigendrug(http://targeting The Surface CD3 antigen of T cells, and its Fc region is modified with amino acids to reduce binding to complements and Fc receptors, reducing its potential toxicityTeplizumab weakens the autoimmune attack on islet beta cells, protecting beta cells from destruction and thus preventing or delaying the onset of type 1 diabetesThe study of the (http:// published recently in the New England Journal of Medicine, that teplizumab can delay the onset of type 1 diabetes for two years or more 　　People at high risk of type 1 diabetes received 14 days of teplizumab treatment (n-44), or placebo (n-32), followed by monitoring the progression of type 1 diabetes in the clinic every 6 months 　　The median time for being diagnosed with type 1 diabetes in the Teplizumab group was 48.4 months, compared with 24.4 months in the placebo group Forty-three percent of Patients in the Teplizumab group and 72 percent of placebo patients were diagnosed with type 1 diabetes during follow-up 　　Statistics show that teplizumab reduced the risk of type 1 diabetes by 59% (HR - 0.41; 95% CI, 0.22 - 0.78; P-0.006)