FDA Reviews Drug That Could Delay Type 1 Diabetes in Young Children

Rebecca Guldberg
2 days ago
3 min read

A promising new development could change how doctors approach type 1 diabetes (T1D) in young children. The U.S. Food and Drug Administration is reviewing an expanded use of a drug called Tzield (teplizumab) that may delay the onset of clinical type 1 diabetes in children as young as 1 year old.

If approved, this would be the first treatment designed to slow the progression of type 1 diabetes before symptoms appear in very young children.

What Is Tzield (Teplizumab)?

Tzield is an immune-modifying medication that works by calming the immune system. In type 1 diabetes, the immune system mistakenly attacks the body’s insulin-producing beta cells in the pancreas. Over time, this leads to the need for lifelong insulin.

Tzield doesn’t cure diabetes — but it can slow down the immune attack, helping preserve insulin production for longer.

The drug is already approved to delay type 1 diabetes in people ages 8 and older who are in the early stages of the disease. Now, researchers want to extend that benefit to much younger children.

Understanding the Stages of Type 1 Diabetes

Type 1 diabetes develops in stages:

Stage 1: Autoantibodies are present, but blood sugar is still normal
Stage 2: Autoantibodies are present and blood sugar is abnormal — but there are no symptoms
Stage 3: Clinical diabetes begins, and insulin treatment is required

This new FDA review focuses on children with stage 2 type 1 diabetes, before they need insulin.

What the FDA Is Reviewing Now

Drug maker Sanofi submitted a supplemental biologics license application (sBLA) asking the FDA to allow Tzield to be used in children ages 1 to 7 with stage 2 type 1 diabetes.

The FDA granted the application priority review, which is reserved for treatments that could significantly improve outcomes for serious diseases. A decision is expected in April 2026.

What the Research Shows So Far

The application is supported by early results from a clinical study called PETITE-T1D, which is testing the safety and dosing of Tzield in young children.

In the study:

Children receive daily IV infusions for 14 days
Researchers monitor them for over two years
Early data suggests the drug is generally safe and works similarly to how it does in older children

More long-term data is still being collected, but the results so far were strong enough for the FDA to move forward with review.

Why This Matters for Families

If approved, Tzield could:

Delay the need for insulin in very young children
Reduce the stress of managing diabetes during early childhood
Give families more time to prepare for life with type 1 diabetes
Preserve insulin production during critical years of growth

Even delaying diabetes by a few years can make a meaningful difference in a child’s quality of life.

What Happens Next

The FDA will continue reviewing the data and is expected to make a decision by spring 2026. If approved, Tzield would become the first disease-modifying therapy available for very young children at high risk of developing type 1 diabetes.

This represents a major step toward preventing or delaying type 1 diabetes — rather than just treating it after diagnosis.

Source: EMPR News – FDA review of teplizumab for delaying stage 3 type 1 diabetes in young children: https://www.empr.com/news/teplizumab-sbla-targets-delay-of-stage-3-t1d-in-young-children/?utm_source=chatgpt.com

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This content is for informational purposes only and should not be taken as medical advice. Always consult a qualified healthcare provider about any questions or concerns regarding your health or treatment options.