FDA OKs Sanofi Diabetes Drug In Newly Diagnosed Pediatric Patients - Sanofi (NASDAQ:SNY)

The U.S.

Food and Drug Administration has granted accelerated approval to Sanofi SA's (NASDAQ:SNY) Tzield (teplizumab-mzwv) to delay the decline of endogenous insulin production in children ages 8 to 17 who have been recently diagnosed with stage 3 type 1 diabetes (T1D).

The decision expands the therapy's use in pediatric patients and was supported by data from the Phase 3 PROTECT study.

PROTECT Trial Showed Slower Decline In Beta Cell Function The FDA based its decision on results from the PROTECT study, which assessed beta-cell function using C-peptide levels measured during a mixed-meal tolerance test.

Tzield significantly slowed the decline in C-peptide levels versus placebo, with a least-squares mean difference of 0.13 pmol/mL (95% CI: 0.09–0.17; p<0.001) at the end of the study.