Tzield™, A Breakthrough FDA-Approved Medication to Delay Type 1 Diabetes
In November of 2022, the United States Food and Drug Administration (FDA) approved a medication called teplizumab-mzwv, branded as Tzield™, that is a major breakthrough for those at risk for developing Type 1 diabetes.
About Type 1 Diabetes
Type 1 diabetes occurs when the immune system attacks and destroys the beta cells that produce insulin in the pancreas. Insulin is the hormone that allows the body’s cells to transform blood sugar into energy. In cases of Type 1 diabetes, the body’s inability to produce insulin means it cannot properly process blood sugar (glucose). Since blood sugar cannot be transformed into energy, glucose builds up in the bloodstream resulting in high blood sugar and leading to a Type 1 diabetes diagnosis.
Although it can develop at any age, most cases of Type 1 diabetes happen early in life with it usually being diagnosed in children and teens. Additionally, an individual is at higher risk for developing Type 1 diabetes if a parent or sibling has already been diagnosed with the disease.
Insulin is Necessary for Everyone with Type 2 Diabetes
Type 1 diabetes is an autoimmune disorder that renders the body unable to produce insulin. Therefore, everyone with Type 1 diabetes needs to supplement the body with insulin treatments. It might be through insulin injections delivered by syringe or insulin pen, or by using a doctor-prescribed insulin pump or a tubeless patch system, such as those offered by OmniPod. Whichever delivery method a person prefers, there is no getting around insulin treatments if you have Type 1 diabetes. The new FDA-approved medication, Tzield, is not a replacement for insulin or even a treatment for someone who has already been diagnosed with Type 1 diabetes.
What is Tzield?
As noted, Tzield isn’t designed to treat Type 1 diabetes. Rather, it’s a breakthrough drug, approved by the FDA for ages 8 and older, that’s been proven to delay the onset of Type 1 diabetes, allowing individuals at risk for the disease to live without the need for insulin treatments for a longer period of time.
Tzield binds to certain immune cells and delays the progression into stage 3 of Type 1 diabetes (the stage when a diabetes diagnosis is made, and insulin treatments are required). Administered by intravenous infusion once a day over a 14-day period, the drug was proven in a double-blind study to significantly delay the development into stage 3 of Type 1 diabetes by an average of over two years compared to individuals who did not receive the drug, but who instead were given placebos.
John Sharretts, Director of the Division of Diabetes, Lipid Disorders, and Obesity at the FDA’s Center for Drug Evaluation Research, said of Tzield’s recent approval, “The drug’s potential to delay clinical diagnosis of Type 1 diabetes may provide patients with months to years without the burdens of the disease.”
The most common side effects of Tzield include decreased levels of certain white blood cells, rash, and headache.
North Carolina Teen Among the Nation’s First to Receive Tzield
High school sophomore, William Troutman, who lives in North Carolina became one of the first people in the United States to use Tzield and his story was featured on vcuhealth.com.
Though he has never experienced any of the symptoms of Type 1 diabetes, William was identified as at risk after his younger sister was diagnosed with the disease in 2020.
Amanda Troutman, William’s mother, heard about Tzield and its clinical studies while listening to a podcast by another parent whose child has Type 1 diabetes. After hearing about the drug and learning the importance of identifying the risk for Type 1 diabetes early, she ordered at-home test kits from TrialNet (the researchers of Tzield) for herself, her husband and William. It turned out that William was positive for two of the hormones associated with Type 1 diabetes.
The family conducted their home tests in 2020. Tzield was not approved by the FDA until November of 2022. Fortunately, at this point William was still in stage 2 of the disease and was approved as a candidate for the drug.
The family traveled some 300 miles to Children’s Hospital of Richmond at VCU, the closest facility available to administer the infusion. Here, William became one of the first individuals in the nation to receive this game-changing medication.
Type 1 Diabetes is on The Rise
While certainly not growing as fast as cases of prediabetes and Type 2 diabetes (neither of which Tzield is approved to prevent and which are closely related to factors such as obesity, diet, and a lack of physical activity), the number of Type 1 diabetes diagnoses is growing in America.
In fact, incidences are increasing between 3% and 5% annually. So, the ability to delay the onset of Type 1 diabetes is a major breakthrough and one with the potential to help thousands of young people across the nation.
Dr. Bryce Nelson, Chief of Endocrinology at Children’s Hospital of Richmond, where William received his treatment, touts the new drug in the vcuhealth.com article stating, “This is the first preventative treatment of Type 1 diabetes and the first novel advancement in diabetes care outside of insulin. This is a really exciting opportunity, but it’s going to require a completely new way of monitoring and diagnosing Type 1 diabetes. Collaboration with pediatrician and general practice providers will be essential in getting kids in for treatment right away.”
New advancements in the care and treatment of diabetes are happening today more than at any other time in history thanks to advancements in our understanding of the disease. The FDA approval of Tzield is certainly another tremendous step forward for those living with Type 1 diabetes.
If you or someone in your family could be at risk for Type 1 diabetes, ask your physician about testing for risk. You can also learn more information about Tzield and testing for Type 1 diabetes risk at Trialnet.org.
We hope you found this post informative and insightful. At Diabetic Warehouse, we’re committed to keeping the diabetes community informed, and helping those with diabetes manage blood sugar with a complete selection of testing and treatment supplies at prices up to 65% less than those found at most pharmacies and suppliers.
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