Official Statement

Dr. Robert Gabbay Statement on FDA Advisory Committee Endorsement of Teplizumab for Delaying Type 1 Diabetes

May 28, 2021 | Arlington, Virginia

The U.S. Food and Drug Administration (FDA) convened the Endocrinologic and Metabolic Drugs Advisory Committee Meeting (EMDAC) on May 27, 2021, to review Teplizumab, which has shown the ability to delay the onset of Type 1 diabetes symptoms by two years. The American Diabetes Association® (ADA) applauds the FDA Advisory Committee’s approval of Teplizumab for those at risk for developing type 1 diabetes (T1D). Click here to view the official comments submitted by the ADA.

In response, Dr. Robert Gabbay, Chief Scientific and Medical Officer for the ADA shared the following:

“This is undoubtedly a historic moment for all people affected by type 1 diabetes (T1D). Teplizumab is the first-ever treatment approved for the prevention of T1D, which is one of the most common chronic diseases developed during childhood. We see the incidence of cases increasing, especially in children less than 5 years of age. T1D is also being diagnosed at an increasing rate in adults. More than 64,000 T1D are diagnosed each year in the U.S., in addition to the estimated 1.6 million people currently living with T1D, and that number is expected to grow to 5 million within the next few decades.”

“People with T1D require life-long insulin replacement therapy, so to be able to provide an individual with a 2-year delay from the symptoms and burden of T1D is a tremendous accomplishment as we look towards finding a cure. There will likely be long-term benefits for blood sugar control and the reduction or delay of acute and long-term complications. The immeasurable benefits of improved quality of life will be felt not only by those diagnosed with T1D, but also by their families.” 

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About the American Diabetes Association
Every day more than 4,000 people are newly diagnosed with diabetes in America. More than 122 million Americans have diabetes or prediabetes and are striving to manage their lives while living with the disease. The American Diabetes Association (ADA) is the nation’s leading voluntary health organization fighting to bend the curve on the diabetes epidemic and help people living with diabetes thrive. For 80 years the ADA has been driving discovery and research to treat, manage and prevent diabetes, while working relentlessly for a cure. We help people with diabetes thrive by fighting for their rights and developing programs, advocacy and education designed to improve their quality of life. Diabetes has brought us together. What we do next will make us Connected for Life. To learn more or to get involved, visit us at or call 1-800-DIABETES (1-800-342-2383). Join the fight with us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn).