The European Medicines Agency (EMA) has recommended marketing authorisation in the EU for Teizeild (teplizumab), the first treatment proven to delay the onset of stage 3 type 1 diabetes in adults and children aged 8 and above with stage 2 disease.
Type 1 diabetes is an autoimmune condition in which the immune system destroys insulin-producing beta cells. Symptoms appear at stage 3, when daily insulin therapy becomes essential. Delaying progression to this stage offers a major benefit, especially for children. Currently, no approved therapies exist to delay the disease.
Teizeild is a monoclonal antibody that slows the immune attack on beta cells. It is administered once daily for 14 days via intravenous infusion.
Evidence comes from a placebo-controlled trial in 76 patients, showing:
• Median time to stage 3 diabetes: 50 months with Teizeild vs 25 months with placebo
• 45% of Teizeild-treated patients progressed to stage 3 vs 72% with placebo
• Additional studies confirmed better preservation of beta-cell function
The most common side effects were reduced white blood cell counts and rash. A small number of patients (2%) experienced cytokine release syndrome.
Teizeild received support under EMA’s PRIME scheme, reflecting its public health importance. The CHMP recommendation now moves to the European Commission for final approval.
Official EMA link.
