FDA Approves Sanofi Teplizumab for Children
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- FDA approved Sanofi's teplizumab on Friday for children aged 8 and older with stage 3 type 1 diabetes.
- Teplizumab was selected for a speedy review program launched last year by former FDA Commissioner Marty Makary, but the agency missed its April 21 decision deadline.
- Sanofi asked to pull teplizumab out of the expedited 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, according to STAT's reporting.
Why it matters: Children with stage 3 type 1 diabetes gain access to teplizumab, but the path to approval was marked by a rare intervention: a political appointee personally overruled FDA staff scientists, and the agency blew past its own April 21 decision deadline — unusual friction in a program designed for speed.
