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FDA Calendar - Sanofi SA

Company Name Sanofi SA
SNY, SNYNF, SAN.PA
Drug Name Tzield (sBLA)
Event Name FDA decision on Tzield to expand to as young as one year old and above to delay the onset of stage 3 type 1 diabetes in patients diagnosed with stage 2 T1D
Event Date 04/29/2026
Outcome Date
Outcome Pending
Drug Status Priority review

FDA accepted for priority review the supplemental biologic license application (sBLA) for Tzield (teplizumab-mzwv) to expand the current age indication from eight years and above, to as young as one year old and above to delay the onset of stage 3 type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D.

If approved, Tzield would be the first disease-modifying therapy to delay the onset of stage 3 T1D in children aged one and older diagnosed with stage 2 T1D.
Rival Drugs
Market Potential
Other Approvals Tzield was first approved in the US in November 2022 to delay the onset of stage 3 T1D in adults and children eight years and older diagnosed with stage 2 T1D. Today, it is also approved in China, the UK, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait for the same indication.

In November 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive recommendation for the same population. Other regulatory reviews are ongoing.
News
FDA Accepts Sanofi's Tzield SBLA Priority Review To Expand Use In Children 1+ For Type 1 Diabetes
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