Sanofi’s Teizeild approved in the EU for patients with stage 2 type 1 diabetes

The European Commission has approved French pharma major Sanofi’s (Euronext: SAN) Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients eight years of age and older with stage 2 T1D. This follows the positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use.

Teizeild is the first T1D disease-modifying therapy approved in the EU, marking a significant milestone in the treatment of this progressive autoimmune disease. The approval is based on positive results from the TN-10 phase 2 study demonstrating that Teizeild delayed the onset of stage 3 T1D by a median of two years compared to placebo, in adults and children aged eight years and older with stage 2 T1D.

“We are pleased that, for the first time, we will be able to offer patients and families in the EU a disease-modifying therapy designed to address the underlying immune process of type 1 diabetes,” said Olivier Charmeil, executive vice president, general medicines, Sanofi, adding: “We remain committed to working with external stakeholders across the EU to bring patients the benefits of Teizeild, a unique therapy that may prevent the natural progression of type 1 diabetes by protecting beta-cell function.”