Tzield (Teplizumab), the first FDA approved drug for delaying the onset of Type 1 Diabetes

By, JASPER VICTORIA

Type 1 Diabetes is an immunological condition in which the immune system attacks the 𝛃-cells of the pancreas that secrete insulin. It is also called as Juvenile-onset diabetes or Insulin-dependent diabetes as it commonly occurs at a young age, usually in children & young adults. 

Patients with Type 1 Diabetes need to regularly monitor their blood glucose levels and have a stable supply of insulin through shots or pumps, in order to manage with their increased blood glucose levels. People with a first-degree relative having Type 1 diabetes appear to have increased risk for the condition.

Tzield (Teplizumab) is approved as an intravenous form of humanized monoclonal antibody that prevents the destruction of the insulin-producing 𝛃-cells. It weakens the signaling pathway by binding to the CD-3 markers of the T-cell receptor - CD-3 complex.

It renders the effector T-cells that are activated inactive and cause cell death, also increasing the release of regulatory cytokines by promoting activity of regulatory t-cells, re-establishing immune tolerance.

76 patients with Type1 Diabetes were enrolled in the randomized, placebo-controlled trial that was double-blinded for the evaluation of safety and efficacy of Tzield. Patients were given either Tzield or placebo once on every 14 days for 51 months and patients who progressed to Stage 3 Type 1 Diabetes were noted. The patients who were given Tzield took 50 months to develop Stage 3 Type 1 Diabetes, whereas, those who were given a Placebo developed Stage 3 Type 1 Diabetes in 25 months.

Hence, Tzield is known to delay the onset of Type 1 Diabetes when taken once for every 2 weeks. Tzield comes with boxed warning for Cytokine release syndrome, decreased lymphocyte count and hypersensitivity reactions as they are associated with side-effects like lymphocytopenia, headache and rashes. In order to avoid such reactions, it is neccessary to be administered with all the age-appropriate vaccines. Any m-RNA vaccine that is live or inactivated however, should not be concurrently used with Tzield.

Provention Bio. was granted the approval by FDA for Tzield through Priority review as Breakthrough therapy for delaying onset of Type 1 Diabetes.