Sanofi’s Teizeild receives European Commission approval, following a positive EMA CHMP opinion, to delay progression to stage 3 type 1 diabetes in stage 2 patients.
Written By: Pharmacally Medical News Desk
Sanofi has received European Commission approval for Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients aged eight years and older with stage 2 T1D. The decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and represents the first disease-modifying therapy approved in the European Union for autoimmune T1D.
This approval signals a shift from treating symptoms after diabetes onset to intervening earlier in the disease process, when pancreatic beta-cell function can still be preserved.
Clinical Evidence Supporting the Decision
The EU approval is based on results from the pivotal TN-10 phase 2 study (NCT01030861), which evaluated whether Teizeild could delay progression from stage 2 to stage 3 T1D. The randomized, double-blind, placebo-controlled trial enrolled 76 participants aged 8 to 45 years who had stage 2 T1D and were relatives of individuals with autoimmune T1D.
Patients received a single 14-day course of Teizeild or placebo. The primary endpoint was time from randomization to clinical diagnosis of stage 3 T1D.
Key findings included:
- Median time to stage 3 T1D was 48.4 months with Teizeild versus 24.4 months with placebo
- Stage 3 T1D developed in 43% of Teizeild-treated patients compared with 72% in the placebo group
- Hazard ratio for progression to stage 3 T1D was 0.41
- At study completion, nearly twice as many patients treated with Teizeild remained in stage 2 T1D compared with placebo (57% vs 28%).
Safety Profile
The safety findings were consistent with earlier studies of Teizeild. The most commonly reported adverse events were:
- Transient lymphopenia (75%)
- Dermatologic reactions, mainly rash (36%)
These events were expected based on the drug’s immune-modulating mechanism and were generally manageable.
How Teizeild Works
Teizeild (teplizumab) is a CD3-directed monoclonal antibody designed to modulate the autoimmune response that drives beta-cell destruction in T1D. By targeting pathogenic T-cells, the therapy aims to preserve remaining insulin-producing beta cells and slow disease progression rather than replacing insulin after beta-cell loss.
Regulatory Status Beyond Europe
Outside the EU, Teizeild is already approved under the name Tzield in the United States, United Kingdom, China, Canada, Israel, Saudi Arabia, the United Arab Emirates, and Kuwait for the same indication. Teplizumab is also gained priority review status by FDA for delaying progression to stage 3 type 1 diabetes in children as young as one year old. Following the positive EU decision, Sanofi has confirmed that it will not pursue a second application at this time for use in newly diagnosed stage 3 T1D, with next steps still under evaluation. Additional regulatory reviews remain ongoing globally.
Understanding Autoimmune Type 1 Diabetes
Type 1 diabetes is a progressive autoimmune condition characterized by immune-mediated destruction of pancreatic beta cells. The disease progresses through four stages:
- Stage 1: Autoantibodies present, normal blood glucose levels, no symptoms
- Stage 2: Autoantibodies plus dysglycemia, still presymptomatic
- Stage 3: Clinical diabetes with hyperglycemia and classic symptoms, requiring lifelong insulin therapy
- Stage 4: Long-standing disease with minimal to no remaining beta-cell function and higher risk of complications
Intervening during stage 2 offers a critical window to delay or prevent progression to insulin-dependent disease.
References
Press Release: Sanofi’s Teizeild approved in the EU for patients with stage 2 type 1 diabetes, 12 January 2026, Press Release: Sanofi’s Teizeild approved in the EU for patients with stage 2 type 1 diabetes
Teplizumab for Prevention of Type 1 Diabetes in Relatives “At-Risk”, ClinicalTrials.gov ID NCT01030861, https://clinicaltrials.gov/study/NCT01030861
Herold KC, et al, An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. N Engl J Med. 2019 Aug 15;381(7):603-613, Epub 2019 Jun 9. Erratum in: N Engl J Med. 2020 Feb 6;382(6):586, PMID: 31180194; PMCID: PMC6776880, https://doi.org/10.1056/nejmoa1902226
The stages of type 1 diabetes, Breakthrough T1D, https://breakthrought1d.org.au/what-is-t1d/stages/