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

The Food and Drug Administration approved teplizumab, a type 1 diabetes drug developed by Sanofi, on Friday for children aged 8 and older diagnosed with stage 3 diabetes. This approval followed a speedy review program initiated last year by former FDA Commissioner Marty Makary, although the agency did not meet its initial decision deadline of April 21. Sanofi had previously requested to withdraw the drug from this expedited program after former top drug regulator Tracy Beth Høg, a political appointee, reportedly disagreed with a staff decision to approve the medication. Høg's involvement in an individual scientific review is considered unusual for a center director.