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