The U.S. The FDA has expanded approval of Tzield (teplizumab), making it the first disease-modifying therapy for children and adolescents newly diagnosed with stage 3 type 1 diabetes. They made the announcement on Monday, June 15.
The updated authorization covers patients aged 8 to 17 who have recently received a diagnosis. Rather than replacing insulin or curing the disease, the treatment slows the decline of natural insulin production.
Regulators previously approved Tzield only to delay progression from stage 2 to stage 3 type 1 diabetes. With this new decision, clinicians can now also use it after they confirm a clinical diagnosis.
How Teplizumab Works in Type 1 Diabetes
Type 1 diabetes is an autoimmune disorder in which the immune system attacks pancreatic beta cells responsible for producing insulin. Teplizumab, a monoclonal antibody, works by targeting immune cells involved in this destructive process.
It aims to limit immune damage to beta cells and preserve insulin production for longer after diagnosis. The FDA notes that maintaining this residual function can support continued endogenous hormone production.
The PROTECT trial supported the approval; it enrolled 328 children and adolescents aged 8–17 who received a diagnosis of stage 3 type 1 diabetes within six weeks of enrollment.
Participants received two 12-day courses of intravenous treatment.After 78 weeks, teplizumab slowed the decline in beta cell function compared with placebo.
Key Study Outcome and FDA Accelerated Approval
The primary outcome measured in the study was C-peptide, a biomarker that reflects the body’s own insulin production. The FDA used its accelerated approval pathway, which is reserved for therapies that may address significant unmet medical needs.
The agency said further studies will track patients and confirm benefits. Tzield is the first approved therapy that targets the underlying cause of type 1 diabetes rather than only controlling blood sugar.
In Brazil, the medication has already been approved to slow progression of stage 2 type 1 diabetes, but it is not yet widely available commercially.
Read the original article on: metropoles
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