JDRF celebrates today’s decision from the U.S. Food and Drug Administration (FDA) to approve Tzield™ (teplizumab-mzwv)—a drug that can delay the onset of type 1 diabetes (T1D) for approximately 2 years in at-risk individuals. This is a watershed moment for the T1D community. For the first time in history, there is now a therapy to address the underlying autoimmunity responsible for T1D. With breakthroughs in disease-modifying therapies—treatments that can slow, halt, or reverse the course of the disease, like Tzield and others in the pipeline—people at risk of T1D, who already have the markers of the disease, will be able to delay the onset of the disease for years. That means potentially years without blood-sugar monitoring, insulin administration, and the fear of short- and long-term complications. This also gives these individuals the opportunity to learn more about disease management and enables next-generation treatments and technologies, which are in clinical trials now, to get to regulatory review.   

We thank the FDA for their thorough review of the evidence, data, clinical benefits, and future impact of Tzield. Tzield and multiple other potential disease-modifying therapies that JDRF has invested research into put us on the critical pathway to finding cures and, one day, preventing T1D entirely.