Sanofi announced that the European Commission has approved Teizeild (teplizumab) for delaying the onset of stage 3 type 1 diabetes (T1D) in adults and children aged eight years and older who are at stage 2 of the disease. This approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use. Teizeild is now the first disease-modifying therapy for T1D approved in the European Union.
The decision was based on results from the TN-10 phase 2 clinical study, which showed that Teizeild delayed progression to stage 3 T1D by a median of two years compared to placebo. The study involved adults and children with stage 2 T1D, characterized by abnormal blood sugar levels and the presence of at least two T1D-related autoantibodies.
Olivier Charmeil, Executive Vice President, General Medicines at Sanofi, said: “We are pleased that, for the first time, we will be able to offer patients and families in the EU a disease-modifying therapy designed to address the underlying immune process of type 1 diabetes. We remain committed to working with external stakeholders across the EU to bring patients the benefits of Teizeild, a unique therapy that may prevent the natural progression of type 1 diabetes by protecting beta-cell function.”
At the conclusion of the TN-10 study, nearly twice as many patients treated with Teizeild remained at stage 2 compared to those given placebo (57% versus 28%). The most common side effects reported were transient lymphopenia—a temporary reduction in certain white blood cells—in 75% of participants and skin rash in 36%.
Teizeild is also approved under different brand names outside Europe—including in the United States, United Kingdom, China, Canada, Israel, Saudi Arabia, United Arab Emirates, and Kuwait—for delaying stage 3 T1D in similar patient groups. Sanofi has decided not to move forward with an additional application for recently diagnosed stage 3 T1D at this time; further regulatory reviews are ongoing.
The TN-10 trial enrolled seventy-six participants between eight and forty-five years old who had relatives living with autoimmune T1D. They received either a single course of Teizeild or placebo over fourteen days. The primary measure was how long it took participants to progress from stage 2 to clinical (stage 3) T1D. Results indicated a median delay to diagnosis of about four years for those on Teizeild compared to just over two years for those on placebo.
Type 1 diabetes is an autoimmune condition marked by destruction of insulin-producing beta cells. It progresses through four stages: presymptomatic stages one and two (with increasing loss of beta cell function), clinical onset (stage three), and long-standing disease often associated with complications (stage four). Management becomes more intensive as symptoms develop due to increased blood sugar levels.
Sanofi describes itself as an R&D-driven biopharmaceutical company focused on creating medicines and vaccines using insights into immune system function.
“We are pleased that, for the first time, we will be able to offer patients and families in the EU a disease-modifying therapy designed to address the underlying immune process of type 1 diabetes,” said Olivier Charmeil, Executive Vice President, General Medicines, Sanofi. “We remain committed to working with external stakeholders across the EU to bring patients the benefits of Teizeild, a unique therapy that may prevent the natural progression of type 1 diabetes by protecting beta-cell function.”
