Sanofi received FDA accelerated approval for Tzield (teplizumab-mzwv).
The treatment targets children aged eight to 17 recently diagnosed with stage 3 type 1 diabetes (T1D).
Tzield delays the decline of the body's natural insulin production.
It represents the first disease-modifying therapy available for this patient population.
The drug addresses the underlying autoimmune cause of the disease.
This approval expands Tzield’s previous indication for delaying stage 3 onset in adults and children with stage 2 T1D.