The US Food and Drug Administration (FDA) has approved Tzield (teplizumab-mzwv), for use in children at stage 2 of type 1 diabetes (T1D) ages one and older.

The drug was first approved in the US in November 2022 to delay the onset of stage 3 T1D in adults and children eight years and older diagnosed with stage 2 T1D.

The FDA has now expanded its use to children as young as one year of age to delay the onset of stage 3 T1D. This means that children at risk for advancing to stage 3 T1D, which is when insulin therapy is required, can get an average of two extra years without T1D.

"This approval opens an important new chapter in diabetes care for young children with stage 2 type 1 diabetes and their families," said Kimber Simmons, MD, MS, Associate Professor of Pediatrics at the Barbara Davis Center, Colorado, US.

"This is especially important because these children are often at the highest risk of progressing quickly and without warning. Delaying the onset of stage 3 type 1 diabetes during the years when management is often most difficult because of a child's small size and dependence on caregivers could have a truly meaningful impact for families," Simmons added.

What is Tzield? How Its Administered?

Developed by drugmaker Sanofi, Tzield is a CD3-directed monoclonal antibody and is the first disease-modifying medicine in T1D.

It is a 14-day, once-daily intravenous (IV) infusion treatment designed to delay the onset of Stage 3 type 1 diabetes in adults and children (aged 8+) with Stage 2 diabetes.

Each dose is administered over at least 30 minutes, usually in a clinical setting, to stop the immune system from destroying insulin-producing beta cells.
Stage 2 T1D is defined by the presence of two or more T1D-related autoantibodies and abnormal blood sugar levels (dysglycemia).

Tzield has also been approved in the EU (under the name Teizeild), the UK, China, Canada, Israel, Saudi Arabia, the UAE, Kuwait, and Brazil to delay the onset of stage 3 T1D in adults and children eight years and older.

The FDA is also reviewing Tzield for a potential indication to delay the progression of stage 3 T1D in patients eight years of age and older who have recently been diagnosed with stage 3 T1D.

The new approval was granted under a priority review process and is supported by one-year data from the PETITE-T1D Phase 4 study, which evaluated safety and pharmacokinetics in young children.

What Is Type 1 diabetes?

Around 2 million Americans have type 1 diabetes, which typically develops in childhood or early adulthood. It occurs when the immune system mistakenly attacks and destroys the islet cells in the pancreas. Without these cells, the body cannot produce insulin.

The progressive autoimmune disease develops in four stages:

The stage 1 T1D is presymptomatic, where the autoimmune attack on the beta cells has started, and this can be detected by the presence of two or more T1D-related autoantibodies in the blood. In this stage, the blood sugar levels are in a normal range.

Stage 2 is also presymptomatic, but blood sugar levels become abnormal due to the progressive loss of beta cells.

Stage 3 (also known as the clinical stage) sets in once a significant portion of the beta cells have been destroyed. At this point, rising blood sugar levels reach the point of clinical hyperglycemia (which defines diabetes), and many people will start to experience the classic symptoms such as: