FDA approves Sanofi's teplizumab for children with stage 3 type 1 diabetes

The FDA announced approval of teplizumab, a Sanofi developed therapy, for children aged 8 and older who have stage 3 type 1 diabetes.

The decision came through the agency’s accelerated review pathway launched last year, although the FDA missed its original April 21 target date.

The approval process was marked by a rare intervention from former CDER director Tracy Beth Høeg, who publicly disagreed with staff recommendations, prompting Sanofi to briefly consider withdrawing the drug from the program.

Regulators ultimately concluded that the benefits outweigh risks, making teplizumab the first therapy authorized to intervene before full onset of type 1 diabetes in pediatric patients.

The move expands treatment options for early stage disease and could influence future pediatric diabetes strategies.