NEW YORK, April 22, 2026 /PRNewswire/ — Breakthrough T1D, formerly JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization, applauds today’s decision by the U.S. Food and Drug Administration (FDA) to approve Sanofi’s Tzield (teplizumab-mzwv) for use in children ages one and older to delay the onset of insulin-dependent T1D. Tzield, the world’s first disease-modifying therapy for T1D, was approved by the FDA in 2022 to safely delay the progression of T1D from stage 2 to stage 3, when insulin therapy is required, in individuals 8 and older. Today’s announcement marks a pivotal milestone for the T1D community, advancing disease-modifying care and extending new hope to young children with stage 2 T1D who are often at high risk of rapidly progressing to insulin-dependent T1D.

“Tzield’s approval for use in children ages one and older marks a defining moment in the treatment of type 1 diabetes,” said Aaron Kowalski, Ph.D., Breakthrough T1D CEO. “By expanding the population eligible for this disease-modifying drug, we are taking a meaningful step toward changing the trajectory of type 1 diabetes. Intervening earlier and slowing the disease’s progression will provide the gift of time to young children and their caregivers, potentially improving lifelong outcomes. I am immensely proud of Breakthrough T1D’s role in advancing the research that made Tzield possible. Breakthrough T1D applauds the FDA for today’s important decision to expand Tzield’s use and thanks Sanofi for its continued commitment to therapies for the type 1 diabetes community.”

From its initial approval to today’s expanded use, Tzield gives people in early-stage T1D the possibility of more years without the daily physical, emotional and financial burdens of the disease. By slowing the progression of T1D, Tzield also delays the onset of complications frequently associated with T1D including eye, kidney, nerve and heart disease.

“The expanded approval of Tzield is encouraging and highlights the importance of Breakthrough T1D’s commitment to advancing next-generation disease-modifying therapies for type 1 diabetes that can change the lives of people with the disease,” said Breakthrough T1D Chief Scientific Officer Sanjoy Dutta, Ph.D. “Today’s decision underscores the critical importance of early detection of type 1 diabetes through screening. The promise of Tzield can only be realized when we can identify those who may benefit from the disease-modifying therapy through screening.”

About Breakthrough T1D, Formerly JDRF
As the leading global type 1 diabetes research and advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while driving toward cures. We do this by investing in the most promising research, advocating for progress by working with government to address issues that impact the T1D community, and helping educate and empower individuals facing this condition. 

About Type 1 Diabetes (T1D) 
T1D is an autoimmune condition that causes the pancreas to make very little insulin or none at all. This leads to dependence on insulin therapy and the risk of short and long-term complications, which can include highs and lows in blood sugar; damage to the kidneys, eyes, nerves, and heart; and even death. Globally, it impacts 9.5 million people. Many believe T1D is only diagnosed in childhood and adolescence, but diagnosis in adulthood is common and accounts for nearly 50% of all T1D diagnoses. The onset of T1D has nothing to do with diet or lifestyle. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. There is currently no cure for T1D. 

Contact:
media@BreakthroughT1D.org

View original content to download multimedia:https://www.prnewswire.com/news-releases/breakthrough-t1d-celebrates-approval-of-tzield-for-use-in-young-children-to-delay-the-onset-of-insulin-dependent-type-1-diabetes-302750664.html

SOURCE Breakthrough T1D, Formerly JDRF