The European Medicines Agency (EMA) has recommended the marketing authorization for Sanofi's Teizeild (teplizumab), a drug that delays the onset of stage 3 type 1 diabetes in patients aged 8 and older who have stage 2 type 1 diabetes.

This is the first drug to receive a recommendation for this preventative indication in the European Union.

Teplizumab works by preserving the function of insulin-producing beta cells in the pancreas and is thought to do so by deactivating the T lymphocytes that attack them. Its development was supported under EMA’s PRIority MEdicines (PRIME) scheme, which accelerates access to therapies addressing urgent unmet needs.

The drug is a monoclonal antibody that targets and deactivates the T lymphocytes that are responsible for attacking the body's own pancreatic beta cells. This helps preserve the function of these cells and delays the onset of stage 3 disease.

The recommendation follows a randomised, placebo-controlled trial of 76 patients with stage 2 type 1 diabetes. Patients treated with Teizeild reached stage 3 after a median of 50 months, compared with 25 months for placebo. Overall, 45% of treated patients progressed to stage 3, versus 72% on placebo, demonstrating significant preservation of pancreatic function.

The approval marks a significant medical advancement because it is the first authorized treatment to delay the onset of type 1 diabetes, which currently has no cure.