Nov. 18, 2022 – The FDA has approved the first treatment to delay the start of insulin-dependent type 1 diabetes, the agency announced this week.

Clinical trials showed the injectable drug, which will be sold under the name Tzield, delayed the start of the disease by more than 2 years, the FDA said. It’s designed for adults and children 8 years and older who have stage 2 type 1 diabetes. Tzield is injected once daily for 14 consecutive days.

When patients with type 1 diabetes progress to stage 3, they usually need insulin shots for life. They also face more serious health risks such as diabetic ketoacidosis, which can be life-threatening, the company that developed the drug, Provention Bio, said in a news release. 

“The onset of stage 3 [type 1 diabetes] is a life-changing moment,” Eleanor Ramos, MD, Provention Bio chief medical officer, said in the release. “Once insulin-producing cells are no longer capable of maintaining normal glycemic control, this irreversible condition can lead to the need, in just one year, for a patient, 1,460 finger sticks to check blood glucose levels, around 1,100 insulin injections, and experiencing an average of 127 episodes of hypoglycemia.” 

Chris Askew, chief executive at Diabetes UK, hailed the FDA approval.

The “approval of teplizumab in the U.S. is the start of a seismic shift in how type 1 diabetes is treated,” he said in a statement. “For 100 years, people living with type 1 diabetes have relied on insulin to treat the condition, and today’s decision means that for the first time, the root cause of the condition – an immune system attack – can be tackled, and type 1 diabetes potentially delayed for up to 3 years.”

With type 1 diabetes, the immune system attacks and destroys cells that make insulin. Tzield works by turning off some of those immune system cells while increasing the share of cells that help moderate the immune response, the FDA said.

“The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease,” John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity at the FDA, said in the release. 

Provention Bio is partnering with Sanofi, a French company, to distribute the drug. Jason Hoitt, Provention's chief commercial officer, said the drug should be available to the public in early 2023, according to Reuters. 

As of 2019, 37.3 million Americans had diabetes – 11.3% of the population, the American Diabetes Association said. About 1.9 million had type 1 diabetes.

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FDA: “FDA Approves First Drug That Can Delay Onset of Type 1 Diabetes.”

Provention Bio: “TZIELD (teplizumab-mzwv) approved by FDA as the first and only treatment indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients aged 8 years and older with Stage 2 T1D.”

Reuters: “U.S. FDA greenlights Provention Bio's diabetes drug.”

American Diabetes Association: “Statistics About Diabetes.”

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