Sanofi’s Teizeild recommended for EU approval by the CHMP for patients with stage 2 type 1 diabetes

Sanofi’s Teizeild recommended for EU approval by the CHMP for patients with stage 2 type 1 diabetes

• Recommendation based on the TN-10 study, demonstrating Teizeild’s ability to delay the onset of stage 3 type 1 diabetes (T1D), compared to placebo, in adults and children with stage 2 T1D
• If approved, Teizeild would become the first disease-modifying T1D therapy in the EU

Paris, November 14, 2025. The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Teizeild (teplizumab) to delay the onset of stage 3 T1D in adult and pediatric patients eight years of age and older with stage 2 T1D.

The positive opinion is supported by positive data from the TN-10 phase 2 study (clinical study identifier: NCT01030861), which demonstrated that Teizeild significantly delayed the onset of stage 3 T1D by a median of approximately two years compared to placebo. At the end of the study, the proportion of patients who remained in stage 2 T1D was twice as high in the Teizeild group as in the placebo group (57% vs 28%). The safety profile was consistent with previous studies of Teizeild, with the most frequently observed adverse events being blood or bone marrow-related (transient lymphopenia) and dermatologic or skin-related (rash).

“We are encouraged by the positive opinion in stage 2 T1D, which represents an important step toward transforming the 100-year-old treatment paradigm for autoimmune T1D,” said Olivier Charmeil, Executive Vice President, General Medicines at Sanofi. “By targeting the disease at an early stage, Teizeild can help prevent the natural progression of T1D, extending the time patients can stay independent of insulin.”

Teizeild (known as Tzield outside the EU) is a CD3 directed monoclonal antibody. It is approved in the US, the UK, China, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait to delay the onset of stage 3 T1D in adults and children aged eight years and older with stage 2 T1D. Following the positive CHMP recommendation and based on conversations with the EMA, at this time Sanofi will not progress its application for recently diagnosed stage 3 T1D and is evaluating next steps. Additional regulatory reviews are ongoing in other jurisdictions around the world.