NUNZIUM

Type 1 diabetes is a disease that occurs when the immune system attacks and destroys the cells that make insulin (pancreatic beta-cells). People with this type of diabetes have increased glucose that requires insulin shots (or wearing an insulin pump) to survive and must check their blood sugar levels regularly throughout the day. Although it can appear at any age, type 1 diabetes is usually diagnosed in children and young adults. A person is at higher risk for type 1 diabetes if they have a parent, brother or sister with type 1 diabetes, although most patients with type 1 diabetes do not have a family history. On November 17, the US Food and Drug Administration - the FDA - approved Teplizumab to delay the onset of stage 3 diabetes in adults and pediatric patients eight years and older with stage 2 diabetes. Teplizumab is a humanized monoclonal antibody, which will be marketed under the brand name Tzield from ProventionBio and Sanofi. Teplizumab acts by binding a specific molecule (CD3 marker) on the surface of specific immune cells-CD8 T lymphocytes - responsible for the destructive action on the pancreatic beta cells. The binding blocks the activation of these cells, thus preventing their damaging effect. Tzield evaluated safety and efficacy in a randomized, double-blind, placebo-controlled trial with 76 patients with stage 2 type 1 diabetes. In the trial, patients randomly received Teplizumab or a placebo once daily via intravenous infusion for 14 days. The trial results showed that over a median follow-up of 51 months, 45% of the 44 patients who received the drug were later diagnosed with stage 3 type 1 diabetes, compared to 72% of the 32 patients who received a placebo. The average time from randomization to stage 3 diabetes diagnosis was 50 months for the patients who received Teplizumab and 25 months for those who received a placebo. These results represent a significant delay in developing stage 3 type 1 diabetes.