Breakthrough T1D Celebrates Approval of Tzield for use in Stage 3 Type 1 Diabetes in the US
Breakthrough T1D, a global research and advocacy organization focused on type 1 diabetes (T1D), has praised the recent decision by the U.S. Food and Drug Administration (FDA) to approve Tzield for use in individuals aged 8-17 diagnosed with stage 3 T1D within eight weeks. Stage 3 T1D is characterized by the body's inability to produce sufficient insulin, necessitating insulin therapy. This approval represents the first instance of a disease-modifying therapy for stage 3 T1D.
The PROTECT study indicated that Tzield successfully preserved beta cell function in individuals with stage 3 T1D and delayed disease progression. Previously approved in 2022 as the first disease-modifying therapy for stage 2 T1D, Tzield remains the only such therapy currently available for T1D.
"The approval of Tzield for individuals ages 8-17 with stage 3 type 1 diabetes is an exciting milestone that reinforces the importance of beta cell preservation," said Aaron J. Kowalski, Ph.D., CEO of Breakthrough T1D. "For the first time, individuals diagnosed with type 1 diabetes in stage 3 will have the option to treat the disease rather than just the symptoms." Kowalski also thanked the FDA for its recognition of the urgent needs in T1D and noted the importance of Sanofi's ongoing research into Tzield.
Sanofi is continuing to study Tzield in this patient population through the confirmatory BETA-PRESERVE study, which aims to provide further information about the drug in the future. As the first FDA-approved therapy for stage 3 T1D, Tzield may pave the way for additional therapies in the T1D pipeline that rely on C-peptide as a clinical trial endpoint.
Breakthrough T1D has been instrumental in the development of Tzield over the years, contributing through research grants and federal funding, as well as investment from the T1D Fund into Provention Bio, which developed the drug before its acquisition by Sanofi in 2023. The organization plans to continue advocating for more therapy options for individuals with stage 3 T1D worldwide.