A Groundbreaking Recommendation for T1D Intervention
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending the approval of Teizeild (teplizumab) for delaying the onset of stage 3 type 1 diabetes (T1D) in adults and children aged eight years and older who are in the earlier, presymptomatic stage 2 of the disease. The recommendation moves the therapy a step closer to formal authorization in the European Union, where no approved treatments currently exist to modify the course of T1D before insulin dependence begins.
Sanofi, the global biopharmaceutical company developing the therapy for the EU market, has positioned Teizeild as part of its broader strategy to advance next-generation immunology treatments. The company, which leverages accelerated R&D platforms and AI-driven drug discovery, continues to expand its pipeline across autoimmune, inflammatory, and metabolic diseases. Sanofi says its mission “pursuing the miracles of science to improve people’s lives”, underpins its efforts to address unmet needs and transform longstanding approaches to chronic and life-altering conditions.
Evidence from Clinical Trials
CHMP’s endorsement is backed by evidence from the Phase 2 TN-10 study (NCT01030861), a pivotal trial evaluating whether teplizumab could delay the clinical onset of T1D in individuals who had early signs of autoimmunity and dysglycemia but had not yet progressed to insulin dependence. The study demonstrated that Teizeild delayed progression to stage 3 T1D by a median of about two years compared with placebo. By the study’s conclusion, 57% of participants treated with Teizeild remained in stage 2 T1D, compared with 28% of those in the placebo group—representing a meaningful delay in the onset of symptomatic disease.
The safety profile observed in the trial was consistent with prior research on teplizumab. The most common adverse events included transient lymphopenia, generally resolving without intervention, and mild dermatologic symptoms such as rash. No unexpected safety concerns emerged, supporting CHMP’s positive benefit-risk assessment for patients at high risk of progressing to overt T1D.
A Paradigm Shift in Disease Management
This milestone is seen as an important advance in rethinking how autoimmune type 1 diabetes is managed. For more than a century, treatment has typically begun only after the onset of clinical stage 3 disease, when patients become symptomatic and require lifelong insulin therapy. Early intervention, according to experts, represents a shift toward disease modification rather than reactive management.
Olivier Charmeil, Executive Vice President of General Medicines at Sanofi, said early action has the potential to meaningfully alter the disease trajectory. “Early intervention with Teizeild can extend the period during which patients remain insulin-independent,” he noted, emphasizing the significance of giving at-risk individuals and families more time before the onset of burdensome daily management.
Global Reach and Future Outlook
Teizeild—marketed as Tzield in markets outside the EU—is an anti-CD3 monoclonal antibody and the first therapy shown to delay the clinical onset of T1D. It is already approved in the United States, United Kingdom, China, Canada, Israel, Saudi Arabia, the United Arab Emirates, and Kuwait. These approvals reflect growing global recognition of the need for presymptomatic intervention, particularly as screening programs for at-risk individuals become more widespread.
Following discussions with EMA, Sanofi has confirmed that it does not intend to pursue approval for use in recently diagnosed stage 3 T1D patients at this time. Instead, the company is focused on the stage 2 indication and is evaluating its regulatory strategy for future submissions. Additional reviews of teplizumab continue across several international jurisdictions as health systems increasingly explore early-diagnosis pathways and immunomodulatory approaches to T1D.
If approved by the European Commission, Teizeild would become the first disease-modifying therapy available in the EU for delaying the onset of stage 3 T1D, potentially reshaping early intervention and screening strategies across the region.
