FDA Approves Sanofi's Teplizumab for Children with Type 1 Diabetes
The U.S. Food and Drug Administration (FDA) has approved Sanofi's teplizumab, a drug for type 1 diabetes, targeting children aged 8 and older with stage 3 of the condition. This approval follows a period where the drug's review was reportedly complicated by a disagreement between FDA career staff and a political appointee, Tracy Beth Høeg, concerning the drug's initial approval decision. Sanofi had previously requested to remove its drug from an expedited review program.
The U.S. Food and Drug Administration (FDA) announced on Friday its approval of teplizumab, a drug developed by Sanofi for the treatment of type 1 diabetes. The approval specifies its use for children aged 8 and older who have been diagnosed with stage 3 of the condition.
The drug's journey to approval included its selection for a speedy review program, which was initiated last year by former FDA Commissioner Marty Makary. Despite this accelerated pathway, the agency did not meet its target decision date of April 21.
Reports from STAT News indicated that Sanofi had previously requested to withdraw its drug from the expedited program. This request reportedly stemmed from a disagreement involving Tracy Beth Høeg, a former top drug regulator and political appointee. Høeg reportedly disagreed with a staff decision to approve the drug.
According to STAT News, it is uncommon for a center director, particularly a political appointee like Høeg, to become involved in individual scientific review processes.
(Source: STAT News)
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