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United StatesMedicine8 days ago

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

The FDA has approved teplizumab, a type 1 diabetes drug developed by Sanofi, for children aged 8 and older with stage 3 diabetes. The approval process involved a speedy review program initiated by former FDA Commissioner Marty Makary. However, the FDA missed its target decision date of April 21. Sanofi had requested to withdraw its drug from the program following disagreements between former top drug regulator Tracy Beth Høeg and staff regarding the approval decision. It is uncommon for a center director, especially a political appointee like Høeg, to participate directly in individual drug审批s

Former CDER head Tracy Beth Høeg had disagreed with staff on approval

Anna Yeo/STAT

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.

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FDA Reporter

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.

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Source document: Food and Drug Administration (FDA)

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STAT NewsIndependentCenter8 days ago
STAT+: FDA approves Sanofi diabetes drug for children with stage 3 diabetes

The FDA has approved teplizumab, a type 1 diabetes drug developed by Sanofi, for children aged 8 and older with stage 3 diabetes. The approval process involved a speedy review program initiated by former FDA Commissioner Marty Makary. However, the FDA missed its target decision date of April 21. Sanofi had requested to withdraw its drug from the program following disagreements between former top drug regulator Tracy Beth Høeg and staff regarding the approval decision. It is uncommon for a center director, especially a political appointee like Høeg, to participate directly in individual drug审批s

Bias read (Center): The article presents factual information about the FDA's approval of a diabetes drug without overtly favoring any political perspective. It includes details about the approval process, timeline, and internal disagreements within the FDA, but does not exhibit biased language or selective sourcing.

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