Type 1 Diabetes Drug That Delays Onset Finally Got The FDA Stamp Of Approval


Those who suffer from Type 1 diabetes and who are scared to pass it off to their children can now breathe a sigh of relief. Tzield may be the solution as it has shown to slow the immune system’s attack on insulin-producing cells that are found in the pancreas. This injectable medicine is the first that belongs to a new family of medicines. This has found to halt the progression of type 1 diabetes, at least for a few years.

The U.S. Food and Drug Administration (FDA) has approved, for the first time ever, a drug that was designed to stall and delay the development of type 1 diabetes for those who suffer or who may suffer from it.

The intravenous drug is called teplizumab-mzwv (Tzield). This is perfect for both adults and children 8 years and older, particularly those who are at an extreme risk of developing type 1 diabetes but have not yet been diagnosed. This is also for those who fear that they may become dependent on insulin shots.

Tzield belongs to a new family of medicines. As mentioned, its main goal is to stall the immune system’s attack on insulin-producing cells, which is the underlying cause of the disease.

“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, MD. He is the director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. He also release a statement regarding this. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”

When it comes to type 1 diabetes, the pancreas stop making the sufficient amount of insulin, which is a hormone that helps the body convert sugars from food into energy. Without this, the sugars accumulate in the bloodstream. When left untreated, this leads to serious complications such as heart disease, kidney failure, amputations, and blindness. Those who have been diagnosed with this will be dependent on lifelong treatments with insulin shots or will need to use an insulin pump.

According to the American Diabetes Association, those who develop type 1 diabetes inherit the risk factors from both parents. People with a parent or a sibling with it can request for blood tests to see if they are prone to it as well. Once these attacks happen, they almost always get type 1 diabetes, which is the kind that needs insulin shots. Of course, the progression differs from one person to the next.

Tzield has the ability to slow down the progression for those who have the stage 2 disease. According to Emory University, stage 2 hasn’t fully blown yet and they do not require treatment at the moment, but those on the stage may see damaged insulin-producing cells in the pancreas and abnormal levels of blood sugar.

The FDA gave their approval to Tzield because of the clinical trial that involved 76 patients who suffered from the stage 2 disease. Here, scientists had randomly the patients with daily infusions of either Tzield or a placebo for two weeks.

The researchers then performed a median follow-up period of 51 months. This was when they saw that only 45 percent of the patients in the Tzield group developed type 1 diabetes. They placed the data side by side with the 72 percent with the placebo.

The average progression time for type 1 diabetes was also twice as long with the help of Tzield. They found that the disease happened 50 months after as opposed to the 25 months that happened in the placebo group.

As for children who were at a high risk, stalling this disease by several years can be important especially when you need to provide them with time for maturity so that they will know how to navigate their life as they live with this disease.

“A delay in the onset of type 1 diabetes will have a tremendous impact on the daily lives of people at risk for diabetes, their families, and the overall health system,” shared Aaron Kowalski, PhD. He is the chief executive officer of the Juvenile Diabetes Research Foundation. He released a statement after the FDA approved the drug.

“It would free them from the constant burden and stress of blood-sugar monitoring and insulin administration,” Dr. Kowalski said. “It would free them from the worry and fear of short- and long-term complications, while giving them the opportunity to learn more about disease management.”

As for the side effects of Tzield, the most common ones reported by FDA were decreased white blood cell levels, rashes, and headaches. There are those that had the rare, more serious ones such as infections, interference with usual vaccinations, and what’s often referred to as cytokine release syndrome. The latter refers to when the immune system goes into overdrive and results to fever, body aches, and sometimes, organ failure.

The approval was delayed by the FDA in July 2021 when regulators required further information about the body’s response to it. Then, it was moved again in June 2022 because the FDA needed to extend the review period for it, as its developer Provention Bio shared then.