Doctors hailed the FDA approval as a "watershed moment."
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.
Teplizumab, 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 of insulin-dependent Type 1 diabetes for 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."
Tzield was approved to delay the onset of stage 3 Type 1 diabetes in adults and children ages 8 and up who currently have stage 2 Type 1 diabetes. The medication is thought to slow down the body's attack on its own insulin-producing cells and thus give people more time before they become dependent on pharmaceutical insulin. Tzield is not suitable for people with insulin-dependent Type 1 diabetes, people who are pre-Type 2 diabetics or those with type 2 diabetes.
"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."
Type 1 diabetes is a chronic autoimmune condition in which the pancreas does not produce insulin, the vital hormone responsible for controlling the amount of glucose in the body's bloodstream. People with Type 1 diabetes have increased glucose that requires them to get insulin shots or wear an insulin pump to survive.
People with a family history of Type 1 diabetes or are otherwise concerned about developing the disorder can get a blood test processed through a lab that can detect autoantibodies. Studies have shown that 75% of people with these diagnostic markers usually become insulin-dependent within five years and nearly 100% at some point in their lifetime.
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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