Sanofi wins EU approval for its type 1 diabetes biologic Teizeild

The European Commission has approved Teizeild (teplizumab) as the first disease-modifying treatment for type 1 diabetes in the EU.

The CD3-directed biologic is indicated to delay the onset of stage 3 type 1 diabetes (T1D) in patients eight years old and over with stage 2 T1D.

Olivier Charmeil, Executive Vice President for General Medicines at Sanofi, explained that the firm is “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”.

The Commission’s decision comes after UK authorisation of Teizeild last August by the MHRA and follows a positive opinion from its advisory Committee for Medicinal Products for Human Use (CHMP).

While the FDA approved the monoclonal antibody in 2022 to delay the onset of stage 3 type 1 diabetes in these patients, Sanofi is not currently planning to apply for approval of Teizeild in recently diagnosed stage 3 T1D.

The Commission’s current approval is based on positive results from the TN-10 phase II study which showed that Teizeild delayed the onset of stage 3 T1D by a median of two years compared to placebo.

The study evaluated individuals aged eight years and older with stage 2 T1D. The proportion of these patients who remained in stage 2 T1D was almost twice as high in the Teizeild group as in the placebo group (57 percent vs 28 percent).

Commenting on the MHRA’s decision last year, Parth Narendran, Professor of Diabetes Medicine at the University of Birmingham, said: “Teplizumab essentially trains the immune system to stop attacking the beta cells in the pancreas, allowing the pancreas to produce insulin without interference. This can allow eligible patients to live normal lives, delaying the need for insulin injections and the full weight of the disease’s daily management by up to three years.”