USA – FDA approves first drug to delay onset of type 1 diabetes

The US Food and Drug Administration (FDA) has approved Provention Bio’s Tzield (teplizumab-mzwv) as the first and only immunomodulatory treatment to delay the onset of stage 3 type 1 diabetes in adult and paediatric patients aged eight years and older who have stage 2 type 1 diabetes.

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The company submitted positive results from the randomised, double-blind, placebo-controlled TN-10 trial that included 76 patients with stage 2 type 1 diabetes.

Results showed that, after an average follow-up of 51 months, only 45% of 44 patients involved in the trial went on to develop stage 3 type 1 diabetes. All 44 patients were given Tzield intravenously once a day for two weeks.

By comparison, in the placebo group, 72% of the 32 patients were later diagnosed with stage 3 type 1 diabetes…

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