First Ever Drug Approved by FDA to Delay Onset of Type 1 Diabetes

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Highlights:

• Type 1 diabetes is when the pancreas does not make enough insulin if at all and affects over 9 million people worldwide, mostly children
• For the first time ever, FDA has approved a drug called Teplizumab, which is an immunotherapy drug that can delay the onset of type 1 diabetes
• Teplizumab delayed the onset of type 1 diabetes by almost 3 years

The Food and Drug Administration (FDA) approved the first drug to delay the onset of Type 1 diabetes. The drug, called Teplizumab (Tzield), is a monoclonal antibody injection. It's been approved for people ages 8 and older who have early signs of Type 1 diabetes (1^✔).

Type 1 diabetes is an autoimmune disease which occurs when the body's immune system attacks and destroys insulin-producing beta cells in the pancreas, causing high blood glucose levels. Insulin is a hormone that tell cells to use sugar from the bloodstream to make energy.

‘Teplizumab, an immunotherapy drug is the first ever drug to be approved by FDA to delay the onset of type 1 diabetes.’

Researchers at Indiana University School of helped conduct clinical trials and led data collection and analysis of the drug. "Since the early '90s, people have been trying to delay onset of type 1 diabetes. This is the first successful drug to do that," said researchers (2^✔).

Teplizumab's Role in Delaying Onset of Type 1 Diabetes

Teplizumab is an immunotherapy drug designed to interfere with the body's immune destruction of its own beta cells. Teplizumab binds to certain immune system cells and delays progression to stage 3 type 1 diabetes. Teplizumab may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response. Teplizumab is administered by intravenous infusion once daily for 14 consecutive days.

Teplizumab'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.

In the trial, patients randomly received Teplizumab or a placebo once daily via intravenous infusion for 14 days. The primary measure of efficacy was the time from randomization to development of stage 3 type 1 diabetes diagnosis.

The trial results showed that over a follow-up of 51 months, 45% of the 44 patients who received Teplizumab were later diagnosed with stage 3 type 1 diabetes, compared to 72% of the 32 patients who received a placebo. The mid-range time from randomization to stage 3 type 1 diabetes diagnosis was 50 months for the patients who received Teplizumab and 25 months for those who received a placebo. This represents a statistically significant delay in the development of stage 3 type 1 diabetes.

The most common side effects of Teplizumab include decreased levels of certain white blood cells, rash and headache. The use of Teplizumab comes with warnings and precautions, including premedicating and monitoring for symptoms of Cytokine Release Syndrome; risk of serious infections; decreased levels of a type of white blood cell called lymphocytes; risk of hypersensitivity reactions; the need to administer all age-appropriate vaccinations prior to starting Teplizumab; as well as avoiding concurrent use of live, inactivated and mRNA vaccines with Teplizumab.

Nearly three years delay for the onset of type 1 diabetes is an exponential deal because even if someone has the newest technologies for delivery of insulin, it still puts a strain financially and psychologically which comes with the diagnosis.

It changes the way people with type 1 diabetes and those at risk of it are treated. Relatives of people who have type 1 diabetes have nearly 100 percent chance of developing the disease themselves.

The study results are of great worldwide importance, especially for the relatives of people with type 1 diabetes who are themselves at 15 times greater risk of developing the disease than the general U.S. population. These findings show that type 1 diabetes can be delayed with therapies that influence the immune system.

Till date, identifying people with type 1 diabetes could be done easily, but nothing could be done to mitigate the risk which left families just waiting for the disease to consume them. The option to delay the onset gives hope to anyone who is at risk along with their families.

References:

1. FDA Approves First Drug That Can Delay Onset of Type 1 Diabetes - (https:www.fda.gov/news-events/press-announcements/fda-approves-first-drug-can-delay-onset-type-1-diabetes)
2. IU research contributes to first FDA-approved drug to delay onset of type 1 diabetes - (https:medicine.iu.edu/news/2022/11/teplizumab-research-fda-approval)

Source: Medindia

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