Sanofi’s Tzield type 1 diabetes immunotherapy wins UK first

Sanofi’s Tzield (teplizumab) has become the first immunotherapy to be approved for type 1 diabetes in the UK after being authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).

The UK regulator granted the treatment a licence for individuals aged eight years and older with Stage 2 type 1 diabetes.

Sanofi’s General Manager, General Medicines UK and Ireland Ahmed Moussa said: “One hundred years ago, the discovery of insulin revolutionised diabetes care. Today’s news marks a big step forward. We are now working with reimbursement bodies with the hope of securing timely access for eligible patients across England and Wales.” 

Tzield is administered via intravenous infusion once per day for 14 days and indicated to delay the onset of Stage 3 type 1 diabetes by an average of three years. It works by binding to specific immune system cells to slow disease progression and can deactivate immune cells that destroy insulin-producing cells, as well as boosting the number of cells that control the body’s immune response.

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.”

Broadening the treatment landscape for type 1 diabetes with Tzield

Sanofi released promising Phase III data from the PROTECT clinical trial in October 2023. The study demonstrated the disease modifying therapy’s ability to slow progression by enabling a superior preservation of beta cells compared to placebo. The trial evaluated newly diagnosed children and adolescents with Stage 3 type 1 diabetes.

Dr Kevan Herold, Long Professor of Immunobiology and of Medicine (Endocrinology), Yale School of Medicine and Primary Investigator of PROTECT, noted the importance of expanding the treatment landscape, following release of Sanofi’s Tzield Phase III data in 2023. “Beta cell preservation remains a meaningful unmet need for all patients with diabetes,” he said.

The MHRA’s new approval follows the US Food and Drug Administration (FDA) authorisation of Tzield in November 2022. The agency granted its approval as the first drug to delay the onset of Stage 3 type 1 diabetes in individuals over eight years old with Stage 2 type 1 diabetes.