Nov 18, 2022 - Health

FDA approves first drug that can delay Type 1 diabetes

A sign for the Food And Drug Administration is seen on July 20, 2020, in White Oak, Maryland. Photo: Sarah Silbiger/Getty Images

The Food and Drug Administration on Thursday approved the first treatment that can delay the onset of Type 1 diabetes.

Why it matters: The new drug, called Tzield (teplizumab-mzwv), can delay the onset of stage 3 Type 1 diabetes in adults, and in pediatric patients 8 years and older who have stage 2 Type 1 diabetes, per the FDA.

  • It does not, however, cure or prevent Type 1 diabetes, which often emerges in teenagers.

Details: The drug is made by Provention Bio in partnership with Sanofi and will be marketed in the U.S. under the brand name Tzield, the New York Times reports.

  • The drug should be available by the end of the year, Provention said.

By the numbers: The drug will cost $13,850 a vial or $193,900 for the 14-day treatment, Provention said in an investor call Friday per the Times.

What they're saying: "Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients," Dr. John Sharretts, head of the diabetes division at the FDA’s Center for Drug Evaluation and Research, said in a statement.

  • "The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease."
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