The European Medicines Agency (EMA) has recommended granting EU-wide marketing authorisation for Teizeild (teplizumab) — a first-of-its-kind therapy designed to delay the onset of stage 3 type 1 diabetes in adults and children aged 8 years and above who are in stage 2 of the disease.
This marks a major milestone in diabetes care, particularly for children and families facing the lifelong burden of insulin therapy.
A First for Type 1 Diabetes Prevention
Teizeild is being developed by Sanofi Winthrop Industrie, and it previously received PRIME designation in 2019 for its potential to address a major unmet medical need: delaying or preventing clinical type 1 diabetes (T1D) in at-risk individuals.
If approved by the European Commission, Teizeild will become the first authorised therapy in the EU capable of delaying progression to full-blown, insulin-dependent type 1 diabetes.
Understanding Type 1 Diabetes
Type 1 diabetes is an autoimmune condition where the immune system destroys pancreatic beta cells — the cells responsible for producing insulin, the hormone that regulates blood sugar.
Without treatment, rising blood glucose leads to symptoms such as:
- Excessive thirst
- Hunger
- Frequent urination
- Weight loss
- Fatigue
Long-term, the disease can damage the heart, nerves, eyes, kidneys, and blood vessels.
Patients require daily insulin injections after reaching stage 3.
The Disease Progression
Type 1 diabetes develops in three stages:
- Autoimmunity begins
- Beta cell loss with abnormal glucose levels (stage 2)
- Symptomatic diabetes requiring insulin (stage 3)
Delaying the onset of stage 3 — especially in children — can significantly reduce complications and improve quality of life.
An estimated 2.2 million people in the EU live with type 1 diabetes, and until now, no approved therapies existed to delay disease progression.
How Teizeild Works
The active ingredient, teplizumab, is an antibody engineered to slow the autoimmune destruction of pancreatic beta cells.
- Administered: Intravenous infusion
- Duration: Once daily for 14 consecutive days
- Goal: Preserve beta cell function and delay the need for insulin therapy
Clinical Trial Results: A Meaningful Delay
EMA’s recommendation is backed by a randomised, double-blind, placebo-controlled trial involving 76 patients with stage 2 type 1 diabetes.
Key outcomes:
- 50-month median delay to stage 3 in the teplizumab group
- 25-month median delay in the placebo group
- 45% of teplizumab-treated patients progressed to stage 3
- 72% of placebo patients progressed
- Additional studies confirmed better preservation of pancreatic beta cell function with teplizumab
This represents a significant and clinically meaningful delay for a disease that often begins in childhood.
Safety Profile
The most common side effects observed with Teizeild include:
- Lower levels of white blood cells (lymphocytes, leucocytes, neutrophils)
- Rash
- Reduced blood bicarbonate, which can lead to metabolic acidosis
A serious adverse reaction, cytokine release syndrome, occurred in around 2% of patients and can cause fever, vomiting, breathing difficulty, headaches, and low blood pressure.
Risk mitigation strategies are included in the medicine’s product information and risk management plan.
Next Steps Toward Patient Access
EMA’s Committee for Medicinal Products for Human Use (CHMP) recommendation is an intermediate step.
The opinion now moves to the European Commission, which will make a final decision on EU-wide marketing authorisation.
Once approved, pricing and reimbursement decisions will be made individually by EU Member States, based on national healthcare policies.
