FDA approves revolutionary new type I diabetes drug in the US

The Food and Drug Administration (FDA) recently approved a new treatment, Tzield, which delays the onset of later stages of type I diabetes in the US. 

Currently, about 8.7 million people have type I diabetes globally. In the US, about 1.9 million people have type I diabetes. 

Type I diabetes is a chronic condition where the pancreas is unable to make sufficient amounts of insulin, which prevents the body from using glucose to produce energy. The condition most commonly occurs in children and young adults. This occurs because the immune system of people with type I diabetes attacks and destroys the pancreatic cells producing insulin. 

According to medical professionals at the Cleveland Clinic, those with type I diabetes experience symptoms such as increased thirst and hunger, frequent urination, fatigue, and unexplained weight loss. Furthermore, if diagnosis of this condition is delayed and it continues to progress, it can be life-threatening because of diabetes-related ketoacidosis (DKA), which causes blood to turn acidic due to the body breaking down fats for energy and producing ketones. 

The JDRF, American Diabetes Association, and Endocrine Society stated that the five-year risk of progression to diabetes is 75% in people with markers for autoimmune disease and episodes of uncontrolled blood sugar. One teen with type I diabetes experienced “a tremendous amount of juggling that her peers don’t have to do” because she had to rigorously plan to manage her insulin levels. 

There is currently no cure for type I diabetes; however, this new drug gives patients more treatment options. 

Tzield delays the onset of type I diabetes by preventing misdirected immune cells from attacking pancreatic insulin-producing cells in the body. This is the first treatment that addresses the dysfunctional autoimmunity at the root cause of type I diabetes, while other existing treatments simply mitigate symptoms. 

“The drug’s potential to delay clinical diagnosis of type I diabetes may provide patients with months to years without the burden of the disease,” said Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. 

Clinical trials published by the American Diabetes Association in 2013 found that Tzield delayed development of type I diabetes in at-risk patients for around two years, and even longer for certain participants. While these clinical trials were published in 2013, it has taken time to establish FDA approval for consumer use. 

Olivia Bogillot, Sanofi’s Head of US General Medicines, stated how this is especially significant for youth who are already going through the challenges of growing up and may not have the time to follow intensive type I diabetes treatments. By delaying the condition's onset, youth and their families can enjoy a higher quality of life for a few more years. 

However, for this treatment to have a greater impact, the screening process for type I diabetes will need to expand. Currently, most people being screened have immediate family members with type I diabetes, even though 85% of people with type I diabetes do not have a direct family member with it. 

Looking towards the future of this “game-changing” treatment, “the most important thing right now is finding potential patients,” said Dr. Jeffery Bluestone, a professor in metabolism and endocrinology at the University of California, San Francisco (UCSF).