Rachael Sood, NP, is a diabetes nurse practitioner and Owner and CEO of The Diabetes Collective.

Rachael Sood, NP

The FDA has approved an expanded indication for teplizumab-mzwv (Tzield) to delay the onset of stage 3 

 in children as young as 1 year of age diagnosed with stage 2 disease, extending the therapy's reach from its prior lower age limit of 8 years. The approval, granted under priority review, makes teplizumab the first disease-modifying therapy indicated for this younger age group with stage 2 type 1 diabetes.

The expanded approval indicates teplizumab to delay progression to stage 3 type 1 diabetes in patients with stage 2 disease starting at age 1 year

The decision lowers the prior approved age threshold from 8 years to 1 year

Approval is supported by the PETITE-T1D phase 4, single-arm, open-label study in children under 8 years with stage 2 T1D

Teplizumab is the first disease-modifying therapy approved to delay progression from stage 2 to stage 3 type 1 diabetes

Type 1 diabetes is an autoimmune condition in which immune-mediated destruction of insulin-producing beta cells begins years before clinical symptoms emerge. In young children, this progression can be particularly rapid and difficult to detect, and the burden of stage 3 disease management is compounded by developmental factors including small body size and full dependence on caregivers. Stage 2 disease is defined by the presence of 2 or more type 1 diabetes-related autoantibodies alongside dysglycemia in the absence of symptoms.

The expanded indication is supported by 1-year data from PETITE-T1D, a phase 4 single-arm, open-label, multicenter study evaluating the safety and pharmacokinetics of teplizumab in 23 children < 8 years of age with stage 2 type 1 diabetes. The regimen consists of a once-daily intravenous infusion administered over 14 consecutive days. Parent company Sanofi noted that a supplemental review is also underway for a potential indication to delay progression of stage 3 disease in patients ≥ 8 years of age recently diagnosed with stage 3 type 1 diabetes.

Check out this interview with Rachael Sood, NP, where she discusses what this expanded approval means for clinical practice, how to identify and counsel families of young children with stage 2 type 1 diabetes, and the evolving role of disease-modifying therapy in this population.

: What is the clinical significance of expanding teplizumab use to children as young as 1 year with stage 2 type 1 diabetes?

: This is huge. This is huge news. When I woke up and saw this news, this is the hugest news, probably for this entire year. People that get diagnosed with type 1 diabetes have a complete change in lifestyle. They have to make so many extra decisions. They are dependent on insulin. They are traumatized. They are most often diagnosed in emergency rooms. Many times when we're talking about kids, people don't recognize symptoms early, because kids are kids. They don't really complain. They're just having fun. ‘Oh, I'm hungry, I'm dehydrated, oh, I'm always sick’ but, you know, they just don't complain. They don't recognize things, and we're definitely not getting to our children as quickly.

We also have an issue with access to care. In pediatric clinics, you're seeing 25-30 people a day, and it's really hard to keep up, so these people just go under the radar. Now that this indication is open, I'm hoping that it opens up the opportunity to maybe screen patients to see if they have type 1 diabetes, even early stages, because we actually do have a treatment for them now. I think maybe that was a barrier in some pediatric clinics, that we don't have anything to do about it except just insulin. So why screen or why recognize? I don't know. I don't know what the gate is to you know, but I'm hoping this opens it.

 How might this approval change the way clinicians approach early screening and identification of at-risk patients?

I'm hoping that this indication increases awareness that we do have a medication for this. And just going to the last point, I kind of jumped the gun, but now we have a medication, so let's screen and see, because if they are, then we know, and then we can get them this treatment if they desire it. Now we actually have another option to give them instead of just waiting or referral to clinical trials, or just waiting so your blood sugar gets high and you need insulin. You know, ‘come back when you need insulin.’ I hate that phrase, and I hope we start seeing and hearing less of it.

What factors should clinicians consider when selecting young patients for teplizumab therapy?

Factors to consider for teplizumab, so anyone that has type 1 diabetes stage 2 is going to be a candidate for teplizumab or Tzield, a CD3 directed monoclonal antibody. This is a medication that we make sure that someone is in good health. Obviously, when we give the medication, we do screen people to see if they have any really bad, active viral infections or things like that. It's very, very rare, so most people that are in type 1 stage 2 are candidates for this IV infusion.

How do you see this approval shaping the future of type 1 diabetes management and early intervention?

I think we're not ready, and I don't want to say that, but I'm going to be honest, because we are seeing an increase in type 1. We are seeing an increase in autoimmune diseases just across the US, here, where I am, and across the globe, we are seeing more autoimmune. I think more people are getting more aware of immunology, and we're starting to see that branch off just in the endocrine space, and really in the primary care space, people are getting more interested and invested in it.

I hope this FDA approval kind of kick starts that, hey, like, there's a medication for this. Like there was a reason that this came about. There was a reason to study this. There's a reason to screen, there's a reason to give people time. There's a reason to recognize and see that if we want to keep kids out the hospital, if we want to give mom a few extra years, even if this delays progression for a few years, maybe it doesn't hold the beta cells completely, but if it buys time, that time is so precious, and people deserve that time, kids, moms, parents, families. They deserve this time to not have the burden of having to take insulin and watching their blood sugar 24/7.

Editors’ note: Sood reports no relevant disclosures.

Campbell P. FDA Expands Teplizumab Approval to Children 1 Year & Older to Delay Type 1 Diabetes Onset. HCPLive. April 22, 2026. Accessed April 22, 2026. 

https://www.hcplive.com/view/fda-expands-teplizumab-approval-to-children-as-young-as-1-year-to-delay-type-1-diabetes-onset

US Centers for Disease Control and Prevention. Type 1 Diabetes. May 15, 2024. Accessed April 22, 2026. 

https://www.cdc.gov/diabetes/about/about-type-1-diabetes.html

Articles

FDA expanded teplizumab-mzwv’s indication to delay progression to stage 3 type 1 diabetes in children with stage 2 disease down to age 1 year, following priority review. Stage 2 is defined by multiple T1D autoantibodies with dysglycemia and no symptoms, a period when beta-cell destruction is already underway and can be rapid in very young children. Support comes from PETITE‑T1D (phase 4, single-arm; n=23; <8 years) evaluating safety and pharmacokinetics with a 14‑day IV infusion course. Expanded eligibility may catalyze earlier screening and counseling.

Sood discusses the FDA expansion of teplizumab to children as young as age 1 with stage 2 T1D and the implications for early intervention and delaying disease progression.