Rachael Sood, RN, on the new expanded indication of teplizumab

The US Food and Drug Administration (FDA) has approved an expanded indication for teplizumab-mzwv (Tzield; Sanofi), allowing its use in children as young as 1 year with stage 2 type 1 diabetes (T1D) to delay progression to stage 3 disease. The decision, granted under priority review, was supported by interim data from the phase 4 PETITE-T1D study, which evaluated safety and pharmacokinetics in younger pediatric populations.^1,2

This regulatory milestone introduces a new opportunity for earlier intervention in T1D, a disease that has traditionally been managed only after clinical onset and that requires insulin therapy. In a recent interview, Rachael Sood, RN, MSN, APRN, NP-C, CDCES, a diabetes nurse practitioner and owner and CEO of The Diabetes Collective, a specialty diabetes practice in Louisiana, emphasized the clinical significance of expanding access to teplizumab in younger children.

“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,” Sood said. She described the diagnosis of T1D as a life-altering event for patients and families, noting that many children present late in the disease course, often in emergency settings.

“People who get diagnosed with type 1 diabetes have a complete lifestyle change. They have to make so many extra decisions. They are dependent on insulin. They are traumatized,” she said. “They are most often diagnosed in emergency rooms.”

Sood highlighted that early symptoms in children may go unrecognized, contributing to delays in diagnosis. Limited time and resources in pediatric primary care settings may further complicate early identification. Against this backdrop, the expanded indication for teplizumab may help shift clinical practice toward earlier detection.

“And so now that this indication is open, I’m hoping that it opens up the opportunity to maybe you would want to screen patients to see if they have type 1 diabetes, even early stages, because we actually do have a treatment for them now,” she said.

Teplizumab is a CD3-directed monoclonal antibody designed to modulate the autoimmune response that leads to pancreatic β-cell destruction. By intervening during stage 2 disease—defined by the presence of multiple autoantibodies and dysglycemia—the therapy aims to delay progression to symptomatic, insulin-dependent stage 3 T1D.

According to Sood, the availability of a disease-modifying therapy could address a long-standing gap in care, in which clinicians have historically monitored at-risk patients without offering intervention.

“Now we actually have another option to give them, instead of just waiting for a referral to a clinical trial, or just, ‘Let’s wait so your blood sugar gets high and you need insulin,’” she said. “You know, ‘Come back when you need insulin.’ I hate that phrase, and I hope we start seeing and hearing less of it.”

The approval may also influence clinician awareness and engagement with early-stage disease. Sood noted that the increasing incidence of autoimmune conditions, including T1D, underscores the need for greater attention to immunologic mechanisms and earlier identification strategies.

“I think we’re not ready, and I don’t want to say that, but I’m going to be honest,” she said. “We are seeing an increase in type 1. We are seeing an increase in autoimmune diseases….I hope this FDA approval kind of kick-starts that, hey, like, there’s a medication for this.”

From a clinical standpoint, patient selection for teplizumab involves confirming stage 2 T1D and ensuring overall health status before treatment. The therapy is administered as a 14-day course of intravenous (IV) infusions.

“Anyone who has type 1 diabetes stage 2 is going to be a candidate for teplizumab or Tzield, a CD3-directed monoclonal antibody,” Sood said. “This is a medication that we make sure that someone is in good health….Most people who are in type 1 stage 2 are candidates for this IV infusion.”

Beyond delaying disease progression, Sood emphasized the broader implications for patients and families. Even modest delays in the onset of stage 3 T1D may reduce the immediate burden of disease management during early childhood.

“If it buys time, that time is so so precious, and people deserve that time— kids, moms, parents, families,” she said. “They deserve this time to not have the burden of having to take insulin and watch their blood sugar 24/7.”

The PETITE-T1D study enrolled 23 children younger than 8 years with stage 2 T1D and evaluated a once-daily IV infusion regimen administered over 14 consecutive days. Participants are followed for up to 26 months to assess safety and pharmacokinetics.

With regulatory approvals expanding globally and ongoing investigations into additional indications, teplizumab represents a shift toward earlier, immune-targeted intervention in T1D. For clinicians, the expanded pediatric indication may prompt reconsideration of screening practices, referral pathways, and the timing of therapeutic intervention in at-risk populations.

References

1. Sanofi’s Tzield approved in the US to delay the onset of stage 3 type 1 diabetes in young children. News release. Sanofi. April 22, 2026. Accessed April 22, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-04-22-05-05-00-3278650

2. Sanofi’s Tzield accepted for priority review in the US for young children with stage 2 type 1 diabetes. News release. Sanofi. January 5, 2026. Accessed April 22, 2026.. https://www.sanofi.com/en/media-room/press-releases/2026/2026-01-05-06-00-00-3212420