The FDA has granted accelerated approval to Tzield (teplizumab) to delay the decline in endogenous insulin production in children ages 8 to 17 years recently diagnosed with stage 3 Type 1 diabetes.
The approval makes Tzield the first disease-modifying therapy approved in the U.S. for patients recently diagnosed with stage 3 Type 1 diabetes, according to a June 13 news release from drugmaker Sanofi. The indication was supported by results from the Protect phase 3 study and data from a broader clinical development program involving more than 900 patients who received the therapy.
In the study, patients receiving Tzield experienced a slower decline in insulin production than those receiving a placebo. The FDA granted the indication under its accelerated approval pathway based on evidence of reduced C-peptide decline.
