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FDA approves first drug to delay type 1 diabetes onset

Published : Friday, 18 November, 2022 at 7:38 PM  Count : 585

FDA approves first drug to delay type 1 diabetes onset

FDA approves first drug to delay type 1 diabetes onset


The U.S. Food and Drug Administration said it has approved Provention Bio Inc.'s Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.

Tzield is the first drug approved by FDA that can delay onset of type 1 diabetes, which occurs when the immune system attacks and destroys the cells that make insulin.

People with a type 1 diabetes diagnosis requires insulin shots or wearing an insulin pump to survive and must check their blood sugar levels regularly throughout the day.

Tzield injection binds to certain immune system cells and delays progression to stage 3 type 1 diabetes. The FDA noted that Tzield may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response.

Tzield is administered by intravenous infusion once daily for 14 consecutive days.

The approval was given after Tzield's safety and efficacy were evaluated in a randomized, double-blind, event-driven, placebo-controlled trial with 76 patients with stage 2 type 1 diabetes.

The most common side effects of Tzield were identified as lowered levels of certain white blood cells, rash and headache.

Tzield received Priority Review and Breakthrough Therapy designations. The FDA granted the approval of Tzield to Provention Bio.

END/SZA



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