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, for children aged 8 and older with stage 3 diabetes on Friday. The drug was initially selected for a expedited review program initiated last year by former FDA Commissioner Marty Makary. However, the agency did not meet its April 21 decision deadline. Sanofi had reportedly requested to withdraw its drug from the program after former top drug regulator Tracy Beth Høg disagreed with a staff decision to approve the medication. It is uncommon for a center director, especially a political appointee like Høg, to intervene in specific scientific reviews.