Sanofi (SNY,SAN.PA) announced that the U.S. Food and Drug Administration has 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. The target action date for the FDA decision is April 29, 2026.
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.
Tzield (teplizumab-mzwv) is a CD3-directed monoclonal antibody. Tzield is the first and only disease-modifying therapy in autoimmune T1D; it 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 (Tzield will be known as Teizeild in the EU). Other regulatory reviews are ongoing.
SNY closed on January 2 at $48.23, down $0.23 or 0.47%. In overnight trading at 12:43 AM EST, the stock rose to $49.58, gaining $1.35 or 2.80%.
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