The European Commission approved the use of Teizeild (teplizumab), from Sanofi, making it the first medicine authorized in the European Union able to delay the clinical onset of type 1 diabetes — specifically, the arrival of stage 3 of the disease in people 8 years and older who are in stage 2.
Stage 2 of type 1 diabetes is defined by the presence of several disease-related antibodies and already-detectable changes in glucose, but without the clinical symptoms that mark the start of stage 3, the point that until now was considered the "start" of type 1 diabetes.
The approval was based on results from the phase 2 TN-10 trial, which showed the treatment delays the onset of stage 3 by a median of two years compared with placebo. Teplizumab is a monoclonal antibody that acts on T cells, slowing the autoimmune attack that destroys the pancreas's beta cells.