The U.S. Food and Drug Administration has approved an expanded indication for Sanofi's (EURONEXT: SAN, NASDAQ: SNY) Tzield to delay the onset of stage 3 type 1 diabetes in children as young as one year old. The approval extends the treatment's use from the previous minimum age of eight years to children aged one year and above diagnosed with stage 2 type 1 diabetes.

The FDA granted the approval under a priority review process based on one-year data from the PETITE-T1D phase 4 study, which evaluated safety and pharmacokinetics in young children. The study enrolled 23 participants and involved daily intravenous infusions of Tzield for 14 consecutive days.

Tzield is a CD3-directed monoclonal antibody that targets the immune system in autoimmune type 1 diabetes. Stage 2 type 1 diabetes is characterized by the presence of two or more diabetes-related autoantibodies and abnormal blood sugar levels, occurring before clinical symptoms develop in stage 3.

"This approval opens an important new chapter in diabetes care for young children with stage 2 type 1 diabetes and their families," said Dr. Kimber Simmons, Associate Professor of Pediatrics at the Barbara Davis Center in Aurora, Colorado. "These children are often at the highest risk of progressing quickly and without warning."

The drug was initially approved in the United States in November 2022 for patients eight years and older. Tzield is also approved in the European Union, United Kingdom, China, Canada, Israel, Saudi Arabia, UAE, Kuwait, and Brazil for the same indication in patients eight years and older.

The FDA is separately reviewing Tzield for a potential indication to delay the progression of stage 3 type 1 diabetes in patients eight years and older who have been recently diagnosed with stage 3 disease.