FDA Approves First Drug That Could Delay Onset of Type 1 Diabetes

The US Food and Drug Administration (FDA) approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes.

The drug has been approved for adults and children eight years and older who currently have stage 2 type 1 diabetes.

In type 1 diabetes, the immune system attacks and destroys the cells that make insulin, a hormone produced by the pancreas that regulates glucose levels.

People with a type 1 diabetes diagnosis have increased glucose that requires insulin shots or wearing an insulin pump, as well as checking their blood sugar levels several times a day.

Tzield works by binding to certain immune system cells and delaying progression to stage 3 type 1 diabetes. The drug 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.

A randomized, placebo-controlled study to evaluate Tzield’s safety and efficacy included 76 patients with stage 2 type 1 diabetes. The average time from randomization to stage 3 type 1 diabetes diagnosis was 50 months for the patients who received Tzield and 25 months for those who received a placebo

The most common side effects of Tzield include decreased levels of certain white blood cells, rash, and headache.

According to the Centers for Disease Control and Prevention (CDC), symptoms of diabetes may include:

• Urinating (peeing) a lot, often at night
• Being very thirsty
• Losing weight without trying
• Being very hungry
• Having blurry vision
• Having numb or tingling hands or feet
• Feeling very tired
• Having very dry skin
• Having sores that heal slowly
• Having more infections than usual