FDA Approves Sanofi’s Teplizumab for Type 1 Diabetes in Children
The Food and Drug Administration approved Sanofi’s drug teplizumab on Friday for children aged 8 and older with stage 3 diabetes. According to reporting from STAT, the approval follows a missed April 21 goal date and internal friction regarding the agency’s review process.
Why was the teplizumab approval delayed?
The drug was enrolled in a speedy review program established last year by former FDA Commissioner Marty Makary. However, the agency failed to meet its April 21 deadline to deliver a final decision, according to STAT.
The delay stemmed from internal conflict. STAT reported that Sanofi asked to remove the drug from the speedy program after former top regulator Tracy Beth Høeg disagreed with a staff decision to approve the medication.
Such intervention is uncommon. STAT notes it is rare for a center director, particularly a political appointee like Høeg, to involve themselves in individual scientific reviews.
What happens next for teplizumab?
With the Friday approval, the drug may now become available for the specified pediatric population. The transition from the speedy review program to final approval suggests the drug could soon reach patients with stage 3 diabetes.
The internal disagreement involving Tracy Beth Høeg may lead to further scrutiny of how political appointees influence scientific reviews at the FDA. This conflict could prompt a review of the boundaries between administrative oversight and scientific staff decisions.
Frequently Asked Questions
Who is approved to use teplizumab?
The drug is approved for children aged 8 and older who have stage 3 diabetes.
Which company developed the drug?
Teplizumab was developed by Sanofi.
Why did Sanofi attempt to pull the drug from the speedy review program?
According to STAT, Sanofi made the request after former regulator Tracy Beth Høeg disagreed with a staff decision to approve the drug.
How do you feel about the role of political appointees in scientific drug reviews?