Sanofi’s Teizeild Gains First EU Approval to Delay Type 1 Diabetes Progression

Sanofi has secured European Union approval for Teizeild (teplizumab), a new disease-modifying therapy for people aged eight years and older with stage 2 type 1 diabetes. This decision by the European Commission follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and makes Teizeild the first treatment in the EU shown to delay the onset of stage 3 clinical type 1 diabetes.

The approval is based on positive results from the TN-10 phase II study, where Teizeild significantly extended the time patients remained in the presymptomatic stage compared with placebo, effectively slowing progression of the autoimmune attack on insulin-producing cells. Sanofi says the drug offers patients and families a chance to postpone the need for insulin therapy and reduce the burden of clinical disease onset. Teizeild is already authorised in other markets including the United States, the United Kingdom, China and Canada under the name Tzield for the same indication. The company is not currently moving forward with an application for use in recently diagnosed stage 3 type 1 diabetes but continues regulatory engagement globally.