FDA OKs Sanofi Diabetes Drug In Newly Diagnosed Pediatric Patients

The FDA has granted accelerated approval to Sanofi's Tzield (teplizumab-mzwv) to delay the decline of endogenous insulin production in children ages 8 to 17 recently diagnosed with stage 3 type 1 diabetes. The approval was based on Phase 3 PROTECT study data showing Tzield significantly slowed the decline in C-peptide levels versus placebo. This expands the drug's use following an earlier April 2026 label expansion for stage 2 disease patients as young as 1 year old.