The US Food and Drug Administration said on Friday it has approved the expanded use of Sanofi’s type 1 diabetes injection in children aged 8 to 17 years who were recently diagnosed with stage 3 of the condition.
The FDA had first approved the drug, Tzield, in 2022 to delay the progression of type 1 diabetes from stage 2 to 3 in patients aged 8 years and older. Its label was expanded over time.
In April, the regulator approved use of the drug to delay the progress to stage 3 in patients as young as one year.
The latest label expansion allows use of the drug in children recently diagnosed with stage 3 of the condition, with the aim of slowing down loss of insulin production.
