Tzield Under Expedited Review for Type 1 Diabetes Treatment
Tzield, a monoclonal antibody, has been approved for stage 2 Type 1 diabetes and is now seeking approval for stage 3 disease.
The FDA has accepted Sanofi's supplemental biologics license application for expedited review of Tzield to delay the progression of stage 3 Type 1 diabetes in recently diagnosed adults and pediatric patients.
- Tzield slows beta cell loss in children and adolescents.
- Stage 3 Type 1 diabetes is the clinical stage of the disease, typically when a diagnosis is made after symptoms appear.
- About 2 million Americans have Type 1 diabetes, a disease where the immune system destroys insulin-producing beta cells.
Tzield is a CD3-directed monoclonal antibody approved in 2022 for adults and children with stage 2 Type 1 diabetes to delay progression to stage 3.
Author's summary: Tzield seeks FDA approval for stage 3 Type 1 diabetes treatment.
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