FDA approves first drug that can delay the onset of type 1 diabetes

Today, the United States Food and Drug Administration approved Tzield (teplizumab-mzwv) injection for delaying the onset of type 1 diabetes mellitus stage 3 in adults and pediatric patients 8 years of age and older who currently have stage 2 type 1 diabetes. It is the first treatment approved to delay the onset of the symptomatic stage of type 1 diabetes.

“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, Division Director of Diabetes, Lipid Disorders and Obesity. at the FDA’s Center for Drug Evaluation and Research. in a report. “The drug’s potential to delay the clinical diagnosis of type 1 diabetes can provide patients with months or even years without the burden of the disease.”

Type 1 diabetes is a disease that occurs when the immune system attacks and destroys the cells that make insulin. People with type 1 diabetes have high blood sugar levels that require insulin injections (or wearing an insulin pump) to survive and need to check their blood sugar regularly throughout the day. Insulin injections begin as soon as possible after diagnosis, but symptoms often do not appear until stage 3.

Although the disease can appear at any age, type 1 diabetes is usually diagnosed in children and young adults. A person is at higher risk for type 1 diabetes if they have a parent or sibling with type 1 diabetes, although most patients with type 1 diabetes do not have a family history .

[Related: Why we should be looking out for diabetes in young people with COVID.]

Stage 1 of type 1 diabetes occurs when patients test for two or more diabetes-related autoantibodies, but blood sugar levels remain normal. Once blood sugar levels become abnormal, a patient progresses to stage 2, but there are often still no symptoms. However, Stage 3 is the start of “clinical diagnosis,” where symptoms such as increased thirst and urination, weight loss, blurred vision, and fatigue set in. In some cases, patients at this stage are hospitalized with life-threatening diabetic ketoacidosis. threatening.

Tzield slows the development of stage 3 by binding to certain immune system cells. The injection can deactivate 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 safety and efficacy of Tzield was evaluated in a randomized, double-blind, event-driven, placebo-controlled trial with 76 patients with type 1 stage 2 diabetes. In the trial, patients randomly received Tzield or placebo once daily by intravenous infusion for 14 days. The main measure of effectiveness was the time from randomisation to the development of the diagnosis of stage 3 type 1 diabetes. Doctors followed patients for an average of 51 months after Tzield injections. Forty-five percent of the 44 patients who received Tzield were later diagnosed with stage 3 type 1 diabetes, compared with 72 percent of the 32 patients who received a placebo.

The average time from randomisation to diagnosis of stage 3 type 1 diabetes was 50 months for patients who received Tzield and 25 months for those who received placebo. This represents a statistically significant delay in the development of stage 3 type 1 diabetes.

The most common side effects of Tzield include decreased levels of certain white blood cells (which can lead to an increased risk of infections), skin rashes, and headaches. Use of Tzield comes with warnings and precautions, including guidelines to premedicate and monitor for symptoms of cytokine release syndrome, a series of symptoms associated with T-cell immunotherapy.

Additionally, Tzied poses a risk of serious infections, decreased levels of a type of white blood cells called lymphocytes, and a risk of hypersensitivity reactions. Patients should receive all age-appropriate vaccines before starting Tzield and avoid concurrent use of live, inactivated, and mRNA vaccines with Tzield.

Tzield has received Priority Review and Breakthrough Therapy designations for this indication.

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