FDA Expands TZield Approval to Children as Young as 1 Year Old

Parents and caregivers, here’s a bit of good news. As of this week, Tzield is officially the only medication available that can delay the onset of T1D.

The Food and Drug Administration (FDA) recently approved Sanofi’s Tzield in the U.S. to delay the onset of stage 3 (symptomatic) type 1 diabetes (T1D) in young children. 

This approval expands the eligibility for the medicine from 8 years and older to children as young as 1 year old in patients diagnosed with stage 2 T1D. 

What is Tzield?

Tzield is a medication that reduces the body’s attack on beta cells and protects the body’s ability to make insulin. This delays the onset of T1D and can prevent emergency hospital stays from diabetic ketoacidosis (DKA), as well as make diabetes easier and safer to manage in the first few years after onset.

How does Tzield work?

Tzield can delay the progression of stage two diabetes to stage three diabetes. The delay is variable with an average delay of two years, with some experiencing a much longer delay, protecting the beta cells from damage by the immune system.

If approved for use in stage three diabetes, Tzield can prolong the life of any 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.

Tzield is a one-time treatment given daily for 14 days by IV infusion. Treatment takes about 30 minutes each day. 

What does this mean for children at risk of diabetes?

Researchers are learning more about the onset of T1D all the time. T1D is now known to develop in stages, rather than the all-at-once onslaught of classic symptoms that typically show up in an emergency room at diagnosis: extreme thirst, frequent urination and rapid weight loss. 

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 is a monoclonal antibody therapy and can be given to people who have early signs of T1D autoantibodies (stage 2 T1D). It reduces the body’s attack on insulin-producing beta cells and protects the body’s ability to make insulin for longer. This treatment prevents the progression to stage 3 (diagnosable) T1D for over two years, and can prevent emergency hospital stays from diabetic ketoacidosis (DKA) at diagnosis.

This FDA approval is crucial because it can protect children as young as 1 year of age from the harsh reality of life with T1D for longer.

“The autoimmune attack driving this disease often begins early in life, and the burden that autoimmune T1D poses in this very young population and their families is significant,” said Christopher Corsico, global head of development at Sanofi. “This approval underscores the importance of targeting the immune system early in autoimmune type 1 diabetes, aiming to impact its natural progression by delaying the loss of insulin production in the pancreas.” 

What’s next for Tzield?

Tzield is the only available medication that can effectively delay the onset of T1D. Tzield is also being reviewed by the FDA to eventually delay the progression of T1D in newly-diagnosed patients with stage 3 T1D—essentially extending the “honeymoon” phase of diabetes.

“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, Aurora, Colorado. 

“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.” 

Getting FDA approval is a huge milestone in the science to delay stage 3 T1D in youth and children. Tzield is available now, so talk with your doctor if you or a family member has been diagnosed with stage 2 T1D and you are interested in Tzield therapy to delay the onset of stage 3 T1D.

If you have a family history of type 1 diabetes or you or a family member are at risk for the development of T1D, learn more about primary warning signs, early detection and screening here.