FDA approves first drug to delay onset of Type 1 diabetes


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FDA approves first drug to delay onset of Type 1 diabetes

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The Food and Drug Administration approved a new drug on Thursday that may postpone the onset of Type 1 diabetes, becoming the first of its kind to delay the chronic condition.

The new drug, called Tzield, is given through intravenous infusion. It was approved for people ages 8 and older. The monoclonal antibody drug binds to certain immune system cells affected by the disease and delays the condition from transitioning from stage 2 to stage 3 for approximately two years.


“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients. The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease,” Dr. John Sharretts, the Division of Diabetes, Lipid Disorders, and Obesity director in the FDA’s Center for Drug Evaluation and Research, said.

“This is an historic moment for all people affected by type 1 diabetes (T1D). The approval of Teplizumab, the first-ever treatment approved for the delay of T1D, is a significant step forward for everyone impacted by this chronic disease. The immeasurable benefits of improved quality of life will be felt not only by those diagnosed with T1D, but also by their families. Today is a great day for the diabetes community,” Dr. Robert Gabbay, the chief scientific and medical officer for the American Diabetes Association, said.

People with Type 1 diabetes, a disease that is normally diagnosed in children or young adults, usually need a few injections of insulin into their bodies every day. Diabetes occurs when the immune system destroys cells in the pancreas that make insulin. People with Type 1 diabetes need multiple insulin shots a day or wear insulin pumps, and they must check their blood sugar levels regularly throughout the day.


Common side effects of the drug are decreased levels of certain white blood cells, a rash, and a headache, according to the FDA.

Approximately 28.7 million people across all ages have diabetes, the Centers for Disease Control and Prevention says.

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