Tzield Is the Only FDA-Approved Medication to Delay the Onset of T1D in Those with Stage 2 T1D
Thanks to the FDA’s approval of a novel medication called Tzield in November of 2022, people 8 years of age and older with two or more autoantibodies for type 1 diabetes (Stage 2 T1D) can delay the clinical onset (Stage 3) for several years or longer. Tzield is the first and only disease-modifying therapy in type 1.
The PROTECT Study Evaluated Tzield in Newly Diagnosed (Stage 3) Youth
The makers of Tzield recently conducted a study called PROTECT to see if their medication could also delay the progression of type 1 in those newly diagnosed (Stage 3). PROTECT studied the efficacy and safety of Tzield to slow the loss of beta cells and preserve beta cell function as measured by C-peptide (a marker of insulin production by the pancreas) in children and adolescents aged 8-17 years diagnosed in the preceding 6 weeks with Stage 3 autoimmune T1D. Tzield met the study’s primary endpoint, significantly slowing the decline of C-peptide levels compared to placebo.
What does that mean? Well, for the approximately 60,000 people in the United States diagnosed with type 1 diabetes every year, it could mean they will have a viable treatment option to slow the progression of the disease, offering them the ability to preserve beta cell function for a longer period of time. It will also provide an opportunity for them to learn about the condition and how to manage it, as well as spend more time with blood sugars in a healthy range to protect against long-term complications. It also allows for more time to develop new advances in T1D as well.
The PROTECT study data was presented mid-October at the 49th Annual ISPAD (International Society for Pediatric and Adolescent Diabetes) Conference. Further data showed that on average, study participants on Tzield required numerically fewer insulin units and had numerically higher time in range compared to those on placebo. More people treated with Tzield went into remission as well.
PROTECT Study Data Results Offer Hope for a New Era of Beta Cell Preservation
Dr. Kevan Herold, C.N.H. Long Professor of Immunobiology and Medicine (Endocrinology) at Yale and Primary Investigator of PROTECT, had this to say:
“Type 1 diabetes is a chronic autoimmune disease, driven by the destruction of the insulin-producing beta cells, and as such, beta cell preservation remains a meaningful unmet need for all patients with diabetes. These new results build on the findings from multiple studies across different stages of the disease process, further supporting Tzield’s potential to modulate the progression of T1D.”
This encouraging news offers hope that Tzield could help preserve beta cell function and slow the progression of type 1 diabetes in a larger population of those newly diagnosed with Stage 3 type 1 diabetes around the world. These results mark a new era in the prevention of T1D, as well as preservation in beta cell function for as long as possible.