The FDA has approved a supplemental biologic license application (sBLA) for teplizumab-mzwv (Tzield, Sanofi), expanding its approved age range from 8 years and older down to as young as 1 year of age to delay the onset of stage 3 type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D. The approval was granted under priority review and makes teplizumab the first disease-modifying therapy available for children in this younger age group.
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