Press Release: Sanofi’s Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes

The FDA has granted accelerated approval to Sanofi's Tzield (teplizumab-mzwv) for children aged 8-17 years recently diagnosed with stage 3 type 1 diabetes, making it the first disease-modifying therapy for this indication. The approval is based on the PROTECT phase 3 study showing significant slowing of C-peptide decline compared to placebo. A confirmatory BETA-PRESERVE study is ongoing.