Shots:
- The US FDA has granted accelerated approval to Sanofi‘s Tzield to delay the decline in endogenous (own) insulin production in pts (8-17yrs.) recently diagnosed with stage 3 T1D
- Approval was based on the P-III (PROTECT) trial assessing Tzield (n=217) vs PBO (n=111) in 328 children & adolescents (8-17yrs.) diagnosed with clinical stage 3 T1D in the preceding 6wks.
- Trial showed Tzield slowed the decline in beta cell function as measured by C-peptide levels, alongside safety & efficacy data from a clinical program involving >900 treated pts; confirmatory P-III (BETA-PRESERVE) study is ongoing & enrolling pts
Ref: Sanofi | Image: Sanofi | Press Release
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