Sanofi Wins First EU Approval for Therapy Delaying Type 1 Diabetes Onset
Paris, Monday, 12 January 2026.
On January 12, 2026, Sanofi achieved a significant regulatory milestone as the European Commission approved Teizeild (teplizumab), marking the European Union’s first disease-modifying therapy authorized to delay the onset of stage 3 type 1 diabetes. This approval, applicable to adults and children aged eight and older with stage 2 diabetes, is grounded in compelling data from the TN-10 Phase 2 study. The trial demonstrated that Teizeild could delay disease progression by a median of two years, a critical timeframe for patients and families. Analytically, the results were robust: 57% of patients treated with the therapy remained in stage 2, compared to only 28% in the placebo group. This authorization not only strengthens Sanofi’s immunology portfolio but represents a paradigm shift in diabetes management, moving from reactive symptomatic treatment to proactive preventative intervention for high-risk individuals across the European market.
Clinical Mechanism and Safety Data
Teizeild functions as a CD3-directed monoclonal antibody, distinguishing itself as the first disease-modifying therapy for autoimmune type 1 diabetes (T1D) within the European Union [1][3]. The regulatory endorsement is anchored in the TN-10 phase 2 study (NCT01030861), which enrolled 76 participants aged 8 to 45 who were relatives of individuals with autoimmune T1D and had been diagnosed with stage 2 T1D [3]. While the efficacy data highlighted a median delay of two years in the onset of stage 3 diabetes, the trial also established a clear safety profile [1][3]. The most frequently reported adverse events were transient lymphopenia, affecting 75% of participants, and rash, which occurred in 36% of the study group [1][3].
Global Strategic Expansion
This European authorization complements existing approvals in major global markets. Known as Tzield outside the EU, the therapy secured U.S. approval in November 2022 and is currently authorized in the United Kingdom, Canada, China, Israel, and several Gulf states including the Kingdom of Saudi Arabia [1][3]. Olivier Charmeil, Executive Vice President of General Medicines at Sanofi (NASDAQ: SNY), described the approval as a pivotal moment, stating the company can now offer EU families a therapy “designed to address the underlying immune process of type 1 diabetes” [1][3]. This development reinforces Sanofi’s commitment to its immunology franchise, leveraging its dual listing on EURONEXT (SAN) and NASDAQ (SNY) to drive global commercialization [1][3].
Future Applications
Looking beyond prevention in stage 2 patients, Sanofi is actively exploring the therapy’s utility in later stages of the disease. The company has indicated it is evaluating the next steps for a second application focused on patients with recently diagnosed stage 3 type 1 diabetes [1]. Currently, stage 3 represents the clinical onset requiring daily insulin therapy, while stage 4 involves long-standing autoimmune diabetes with reduced beta cell function [3]. By targeting earlier interventions, Sanofi aims to alter the trajectory of a condition that has historically been managed rather than modified.