Sanofi — Teizeild EMA EPAR public assessment report (EMEA/H/C/005496, 2026)
Sanofi · 2026 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's CHMP recommended marketing authorization for Teizeild (teplizumab) to delay stage 3 Type 1 Diabetes (T1D) onset in patients aged 8+ with stage 2 T1D. Efficacy is primarily supported by the TN-10 study, demonstrating delayed progression. The report details Teizeild's quality, manufacturing, and extensive non-clinical and clinical data, including pharmacokinetics, pharmacodynamics, and immunogenicity. Safety concerns include lymphopenia, infections, and cytokine release syndrome, managed by a comprehensive risk management plan. Despite adverse events, the benefits of delaying T1D onset are considered to outweigh the risks.
Key findings — cited to the page
| Grade 3 or higher Hypoglycaemia in participants 12 to <18 years (Teplizumab) | 5.8 % | · p.172 |
| Grade 3 hypoglycaemia in participants ≥18 years (Control) | 1.3 % | · p.172 |
| Grade 4 (life-threatening) TEAEs (Teplizumab) | 7.8 % | · p.167 |
| Grade 3 case of rash popular | 1 | · p.171 |
| Grade 3 or higher hypoglycaemia (Control) | 5.9 % | all-studies pool · p.172 |
| Grade 3 hypoglycaemia in participants ≥18 years (Teplizumab) | 1.0 % | · p.172 |
| Grade 3 (severe) TEAEs (Teplizumab) | 7.8 % | · p.167 |
| Grade 3 (severe) TEAEs (Control) | 1.7 % | · p.167 |
| Grade 4 (life-threatening) TEAEs (Control) | 1.7 % | · p.167 |
| Grade 3 cases of rash | 3 | · p.171 |
| Grade 3 or higher hypoglycaemia (Teplizumab) | 4.4 % | all-studies pool · p.172 |
| Grade 3 or higher Hypoglycaemia in participants 12 to <18 years (Control) | 7.2 % | · p.172 |
Source: Sanofi ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →