FDA Approves Teplizumab for Children 8 and Older With Stage 3 Type 1 Diabetes
The agency cleared the drug on June 13 after selecting it for an expedited review that missed its April 21 target date. Former CDER head Tracy Beth Høeg had disagreed with staff on the approval decision.
eonline.comThe Food and Drug Administration approved teplizumab on June 13 for children aged 8 and older with stage 3 type 1 diabetes. The drug was developed by Sanofi. The agency had placed the application in a speedy review program launched last year by former FDA Commissioner Marty Makary.
That program set an April 21 target date for a decision, which the FDA missed. STAT previously reported that Sanofi asked to withdraw the drug from the program after former top drug regulator Tracy Beth Høeg disagreed with a staff decision to approve it. It is rare for a center director, and particularly a political appointee like Høeg, to become involved in individual scientific reviews.
The approval covers use in children with stage 3 diabetes, the point at which symptoms typically appear and insulin therapy begins.
