The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 10-7 in favour of the benefits of teplizumab outweighing its risks to support approval of the drug to delay type 1 diabetes.
The EMDAC based its recommendation on data from the phase 2 TN-10 study, which randomly assigned 76 participants aged eight to 45 years old to receive a 14-day treatment course of teplizumab or placebo.
In this study, teplizumab demonstrated a significant delay in the onset and diagnosis of the chronic condition. Compared to placebo, children and adults who were considered high-risk of developing type 1 diabetes saw it delayed by a median of two years.
