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FDA approves Sanofi's Tzield as first disease-modifying therapy for newly diagnosed stage 3 type 1 diabetes in children.

Market News
12 Jun 2026
Sanofi
View Source
Bullish
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The FDA granted accelerated approval to Sanofi's Tzield (teplizumab-mzwv) for children aged 8 to 17 recently diagnosed with stage 3 type 1 diabetes (T1D). Tzield slows the decline of the body's insulin production by targeting the autoimmune process causing T1D. This approval is based on the phase 3 PROTECT study showing significant preservation of beta-cell function compared to placebo. The drug offers a new treatment option at a stage when symptoms typically appear and insulin therapy becomes necessary. Further confirmatory studies are ongoing to verify clinical benefits.

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