PARIS (dpa-AFX) - Sanofi (SNY) announced that the U.S. Food and Drug Administration has granted accelerated approval to Tzield (teplizumab-mzwv) for delaying the decline in endogenous insulin production in children aged 8 to 17 years recently diagnosed with stage 3 type 1 diabetes (T1D). Tzield is not effective as a disease-modifying therapy in non-autoimmune dysglycemic conditions.
The approval was based on results from the PROTECT phase 3 study and additional data from a global clinical development program involving more than 900 patients treated with Tzield.
The most common adverse reactions were lymphopenia, vomiting, rash, leukopenia, diarrhea, neutropenia, increased liver transaminase, and headache. Serious events such as cytokine release syndrome and life-threatening cases of viral reactivation have been reported with Tzield. Patients who are immunocompromised are at increased risk for viral reactivation.
This indication is granted under accelerated approval based on evidence of reduced C-peptide decline. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory study(ies).
Prior to this approval in recently diagnosed stage 3 T1D, in April 2026, the FDA expanded the indication to delay the onset of stage 3 T1D in adults and children eight years and older with stage 2 T1D, to include children aged one year and above. It is also approved to delay the onset of stage 3 T1D in adults and children eight years and older with stage 2 T1D in the UK, the EU (under the name Teizeild), China, Australia, Canada, Israel, Saudi Arabia, the UAE, Kuwait, Brazil and Switzerland. Regulatory reviews are ongoing in other jurisdictions around the world.
SNY closed at $44.25, up $0.14 or 0.32% on June 12. In after-hours trading, the stock slipped slightly to $44.20, down $0.05 or 0.11%.
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