For the first time, the U.S. Food and Drug Administration on Thursday approved a treatment that can delay the onset of type 1 diabetes.
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For the first time, the U.S. Food and Drug Administration on Thursday approved a treatment that can delay the onset ofTeplizumab, a monoclonal antibody that will be marketed under the brand name Tzield from pharmaceutical companies ProventionBio and Sanofi, is administered through intravenous infusion. The injection was shown in clinical trials to delay onset offor patients with autoantibody markers of early risk by over two years, with hopes for some that it can delay onset even longer.
"Today's approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients," said Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA's Center for Drug Evaluation and Research. "The drug's potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.
"This approval is a watershed moment for the treatment and prevention of type 1 diabetes," said Dr. Mark S. Anderson, director of the University of California San Francisco Diabetes Center. "Until now, the only real therapy for patients has been a lifetime of insulin replacement. This new therapy targets and helps to halt the autoimmune process that leads to the loss of insulin.
In 2019, an estimated 28.7 million people of all ages across the United States -- or 8.7% of the country's population -- had diagnosed diabetes, including 1.6 million adults aged 20 and older who reported both having Type 1 diabetes and using insulin. Some 64,000 people are diagnosed with insulin-dependent Type 1 diabetes nationwide each year, according to the U.S. Centers for Disease Control and Prevention.
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