Key Points:
- EMA backs Sanofi’s Teizeild to delay stage 3 type 1 diabetes in the EU.
- Trial results: the drug doubled the time to disease progression (50 vs 25 months).
- First EU option to postpone insulin dependence for type 1 diabetes patients.
The European Medicines Agency (EMA) recommended approval on Nov. 14 for Sanofi Teizeild, Sanofi’s first-in-class drug designed to delay the onset of stage 3 type 1 diabetes. The agency said the treatment, known as Teizeild and chemically called teplizumab, could become the first authorized therapy in the European Union to slow the progression of the autoimmune disease.
Trial Results Released
The recommendation follows a placebo-controlled trial involving 76 patients aged 8 years and older. The study showed that teplizumab doubled the median time to stage 3 onset, extending it to 50 months compared with 25 months for those who received a placebo. Fewer patients advanced to the insulin-dependent stage while on the drug, the EMA said.
Next Steps in Review
The Committee for Medicinal Products for Human Use issued the recommendation, which now moves to the European Commission for a final decision on marketing authorization across the EU.
Sanofi, based in France, developed Sanofi Teizeild to slow the immune system’s attack on insulin-producing cells. The drug is administered as a daily infusion for 14 days. It was first approved in the United States in November 2022 for patients with stage 2 type 1 diabetes, who typically show no symptoms before reaching later stages of the disease.
Sanofi gained full ownership of the therapy in March 2023 when it acquired U.S.-based Provention Bio for $2.9 billion. The acquisition gave the company control of a treatment that addresses a long-standing gap in type 1 diabetes care.
Type 1 diabetes, formerly known as juvenile diabetes, occurs when the immune system destroys beta cells in the pancreas. Once these cells are lost, patients depend on regular insulin injections to maintain blood glucose levels. The condition affects about 2.2 million people in the EU. There is currently no approved treatment in the region that slows its progression.
If the European Commission grants authorization, Sanofi Teizeild would offer the first option for delaying the insulin-dependent stage of the disease, potentially giving patients more time before needing long-term insulin therapy. The review process typically takes several months, after which Sanofi could begin preparing for market launch across member states.
