FDA approves Sanofi diabetes drug for children with stage 3 diabetes

Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health. Confidential tips can be sent on Signal at lizzylaw.53.

WASHINGTON — The Food and Drug Administration on Friday approved teplizumab, a type 1 diabetes drug developed by Sanofi, for children aged 8 and older with stage 3 diabetes. 

The drug was selected to go through a speedy review program launched last year by former FDA Commissioner Marty Makary, but the agency missed its goal date of April 21 to deliver a decision. 

STAT previously reported that Sanofi asked to pull its drug out of the program after former top drug regulator Tracy Beth Høeg disagreed with a staff decision to approve the drug. It’s rare for a center director, and particularly a political appointee like Høeg, to get involved in individual scientific reviews.