Sierra Tanzi
Art Director
Type 1 diabetes is an autoimmune disease in which the immune system attacks healthy beta cells that produce insulin in the pancreas. If someone has this disease, they eventually rely on insulin therapy through either insulin injections via a needle or a medical device used for the administration of insulin. Type 1 diabetes is an incurable disease and until now, there has been nothing to prevent it. This was until the creation of Teplizumab-mzwv, otherwise known as Tzield.
Tzield is a 14-day prescription medicine used to delay the onset of stage 3 Type 1 diabetes in those eight years old and older who tested positive for two or more Type 1 diabetes-related autoantibodies, had abnormal blood sugar levels and did not have Type 2 diabetes. “TZIELD underwent the U.S. Food and Drug Administration (FDA) drug approval process,” said a Sanofi spokesperson. “After years of research and clinical trials, the FDA approved the Biologics License Agreement (BLA) for TZIELD on November 17, 2022.”
With the creation of this new medication, one question remains: How do we know that Tzield is effective and efficient? According to Sanofi, Tzield was evaluated during a registrational clinical trial of 76 patients with stage 2 Type 1 diabetes. During this time, 44 individuals were administered Tzield, while another 32 were administered placebo. These participants were followed up until they were diagnosed with Type 1 diabetes. If someone did not develop the disease, they were followed up for a different period.
“TZIELD does not prevent Type 1 diabetes,” Sanofi stated, “but in this clinical trial, it did delay the median onset of stage 3 Type 1 diabetes by 25 months, or approximately 2 years, compared to placebo.” These patients who progressed to stage 3 Type 1 diabetes eventually required insulin injections for life; however, it has been proven that TZIELD has the potential to delay the onset of stage 3 diabetes for several years. Over a median follow-up time of 51 months, 55% of participants who were given TZIELD were not diagnosed with stage 3 Type 1 diabetes, while 28% of those who were given placebo were diagnosed.
The next stage for TZIELD is, “...to work with families and healthcare professionals alike to increase early screening to detect autoantibodies associated with type 1 diabetes before serious crises occur, and then, where appropriate, ensure eligible patients in need have access to TZIELD.” Sanofi shares. Currently, Sanofi, a pharmaceutical and healthcare company, has a patient support program called COMPASS that assists patients in gaining access to TZIELD and provides them with education and resources related to the medication.
Overall, Tzield has received positive feedback from patients. “We have received positive feedback from patients who have been treated with TZIELD, as well as their caregivers and their physicians.” Sanofi stated. “While everyone who is diagnosed with Type 1 diabetes will eventually require life-long insulin therapy, TZIELD can help delay the onset for stage 3 Type 1 diabetes, which is when insulin is necessary.”
Type 1 diabetes can't be prevented, but it’s possible to detect it early. This disease develops over time and in stages, but there are blood tests that can detect it before any symptoms arise, before insulin is required and potentially before any serious complications occur.
Knowing early can also help people to potentially reduce the risk of going through diabetic ketoacidosis (DKA), which is an extremely serious complication of diabetes that can be life-threatening. If you’re at risk of Type 1 diabetes, it is important to talk to your doctor or healthcare provider about getting screened.
Note: this article was edited per the request of a Sanofi spokesperson to remove the name and instead replace it with "Sanofi" or "Sanofi Spokesperson."
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