FDA Approves Tzield for Pediatric Stage 3 Type 1 Diabetes

A new treatment option is now available for children recently diagnosed with type 1 diabetes (T1D). The Food and Drug Administration (FDA) has approved Sanofi’s Tzield, a monoclonal antibody treatment, for children aged 8 to 17 diagnosed with stage 3 type 1 diabetes (T1D), offering families a way to protect remaining insulin-producing cells and buy critical time before full insulin dependence sets in.

What is Tzield?

Tzield is a medication that reduces the body’s attack on its own beta cells prolonging the body’s ability to make its own insulin. This delays full dependency on a source of insulin and decreases the risk of emergency hospital stays from diabetic ketoacidosis (DKA). Preserving beta cell function can also mean less frequent hypoglycemia, more time in target glucose range and fewer long term complications from T1D.  

According to Tzield clinical trial studies, when taken in early stages of T1D, it can prolong the function of insulin-producing beta cells for up to two years. 

What are the stages of T1D?

Stage 1 T1D 

Can be detected in the blood through autoantibody testing. There are no symptoms and blood sugars are normal, but the immune system has already begun attacking the insulin-producing beta cells. The likelihood of needing to take insulin for T1D within five years is 44%, in 10 years it is 70% and lifetime risk is 100%. 

Stage 2 T1D

Can be detected in the blood through autoantibody testing. There are still no symptoms but now blood sugars have started to rise due to increased beta cell destruction. The likelihood of needing to take insulin for T1D within five years is 75% and lifetime risk is 100%. 

Stage 3 T1D

By this time, blood sugars are high and you’ll have symptoms of T1D. This includes frequent urination, excessive thirst, weight loss and fatigue. Taking insulin for T1D is now required, but the intensity is based on the level of beta cell function remaining in the body.

How does Tzield work?

Tzield is a treatment given by IV infusion. Each infusion takes about 30 minutes.Tzield works to prolong the life of the body’s remaining beta cells, increasing the amount of time a newly diagnosed person stays in the “honeymoon period”—months or years of easier and safer to manage diabetes because the body still makes small amounts of its own insulin.

“We welcome this accelerated approval by the FDA, which recognizes the potential of Tzield to delay the progression of recently diagnosed stage 3 T1D in children aged eight to 17 years,” said Christopher Corsico, global head of development, Sanofi. “Tzield will now offer a new pathway in the treatment paradigm of stage 3 T1D, one that we hope will further enable healthcare providers in the US to take a more proactive approach to disrupt the underlying autoimmune attack against insulin-producing beta cells.” 

This approval is based on the results of the PROTECT phase 3 study and additional data from the global clinical development program of over 900 patients who previously received Tzield.

The study included 328 patients between the ages of 8 and 17 who had been diagnosed with stage 3 T1D within the past six weeks. All patients still had some beta cell function at the time they enrolled in the study.

The study measured how well the beta cells were working at 78 weeks by testing levels of a protein called C-peptide in the blood. C-peptide indicates how much insulin the body is still producing on its own. 

At 78 weeks, patients who received Tzield showed a significantly smaller decline in beta-cell function compared to patients who received the placebo. Meaning that Tzield helped slow down the loss of the body’s own insulin production.

What does this mean for children and families facing a T1D diagnosis?

We now know that T1D is developed in stages, and the development of T1D autoantibodies can begin months or even years before someone needs insulin. A simple autoantibody screening blood test can detect the development of T1D.

Tzield has previously been approved for use in stage 2 T1D for people who tested positive for autoantibodies and before a clinical stage 3 T1D diagnosis. . 

This new approval for use of Tzield at clinical diagnosis  is pivotal because it can still protect beta cell function even at stage 3 clinical diagnosis. But time is of the essence as beta cell function rapidly declines in stage 3 T1D. In fact, it is recommended that Tzield be given within 8 weeks of a new diagnosis. 

What happens now?

Tzield is available now, so talk with your doctor if you or a family member has been diagnosed with T1D and you are interested in Tzield therapy to prolong beta cell (insulin) function.

You’ll need a C-peptide test and an autoantibody test to know if you are eligible. To discuss this with your healthcare provider, check out our conversation guide.