The European Commission has recently approved Teizeild (teplizumab) to delay the onset of stage III type 1 diabetes (T1D) in adult and paediatric patients aged eight years and older with stage II T1D. The approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and marks a milestone in the management of this progressive autoimmune disease.

With this decision, Teizeild became the first disease-modifying therapy for type 1 diabetes approved in the European Union, offering patients a treatment that targets the underlying immune process rather than only managing symptoms. The approval is supported by data from the TN-10 Phase II clinical study, which demonstrated that medicine delayed progression to stage III T1D by a median of two years compared with placebo in both adults and children aged eight years and older.

Commenting on the approval, Olivier Charmeil, Executive Vice President, General Medicines, Sanofi, said the decision enables patients and families in the EU to access a therapy designed to address the root cause of type 1 diabetes. He added, “Sanofi remains committed to working with stakeholders across Europe to bring the benefits of Teizeild to eligible patients by preserving beta-cell function and slowing disease progression.”

At the conclusion of the TN-10 study, nearly 57 percent of patients treated with Teizeild remained in stage II T1D, compared with 28 percent in the placebo group. The safety profile of Teizeild was consistent with earlier studies, with the most commonly reported adverse events being transient lymphopenia and skin-related reactions such as rash.

Teizeild, known as Tzield outside the EU, is already approved in several global markets, including the United States, the United Kingdom, China, Canada, Israel, Saudi Arabia, the United Arab Emirates and Kuwait, for the same indication. Following the positive CHMP recommendation for stage II T1D, the company has decided not to proceed at this time with a second application for use in recently diagnosed stage III T1D, while further regulatory evaluations continue worldwide.

The TN-10 trial was a randomised, double-blind, placebo-controlled Phase II study involving 76 participants aged eight to 45 years who had stage II T1D and were relatives of individuals living with autoimmune T1D. Participants received a single 14-day course of either Teizeild or placebo. The primary endpoint measured the time to progression from stage II to clinical stage III T1D, with secondary endpoints focused on safety and tolerability. Results showed a median time to diagnosis of 48.4 months in the Teizeild group versus 24.4 months in the placebo group, with a significantly lower risk of progression.

Teizeild (teplizumab) is a CD3-directed monoclonal antibody and remains the only approved disease-modifying therapy for autoimmune type 1 diabetes.