STAT+: FDA approves Sanofi diabetes drug for children with stage 3 diabetes

Article excerpt

The FDA approved Sanofi's teplizumab on Friday for children 8 and older with stage 3 type 1 diabetes, marking the first drug cleared to slow or prevent progression of the disease in this age group. The approval came through a expedited review track launched by former FDA Commissioner Marty Makary, though the agency missed its original April 21 decision deadline. Sanofi had previously requested to exit the program after former top regulator Tracy Beth Høeg raised concerns, but ultimately proceeded with approval.