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FDA approves Sanofi's Tzield for children 1+ to delay stage 3 type 1 diabetes onset

Market News
22 Apr 2026
GlobeNewsWire
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Bullish
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The FDA has expanded approval for Sanofi's Tzield (teplizumab-mzwv) to include children aged one year and older with stage 2 type 1 diabetes (T1D), aiming to delay the onset of stage 3 T1D. This marks the first disease-modifying therapy for very young children with this condition, supported by phase 4 study data showing safety and pharmacokinetics. Delaying stage 3 onset is significant as it can ease disease management during early childhood. Tzield is also under FDA review for delaying progression in older patients and is approved in multiple countries for patients eight years and older.

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