First New Type 1 Diabetes Therapy Since Insulin Approved in Australia
The Therapeutic Goods Administration (TGA) has approved Tzield (teplizumab) for use in Australia to delay the onset of stage 3 (clinical) type 1 diabetes in individuals aged 8 years and older with stage 2 type 1 diabetes. This is the first new therapy approved for type 1 diabetes since the discovery of insulin.
Approval and Indication
The TGA has approved Tzield for delaying the progression from stage 2 to stage 3 type 1 diabetes. The therapy is indicated for patients aged 8 years and older who have been diagnosed with stage 2 type 1 diabetes.
Mechanism and Clinical Benefit
Tzield works by targeting the autoimmune attack that destroys insulin-producing beta cells in the pancreas, preserving beta cell function and insulin production. Clinical data indicate that the therapy delays progression to clinical diagnosis and the need for insulin therapy by an average of two years.
"Clinical data indicate that the therapy delays progression to clinical diagnosis and the need for insulin therapy by an average of two years."
Background and Development
Breakthrough T1D, a non-profit organization, has supported the development of teplizumab since 1988 through research funding, clinical trials, and advocacy. The organization also invested in screening infrastructure to identify individuals in early stages of type 1 diabetes.
Disease Context
Type 1 diabetes is an autoimmune condition in which the immune system destroys insulin-producing beta cells in the pancreas. The cause remains unknown, and there is no cure. Approximately 145,000 Australians have type 1 diabetes. An estimated 25,000 people in Australia are living with early-stage type 1 diabetes without knowing it. Screening is the only way to identify candidates for Tzield before symptoms develop.
Access and Future Steps
Tzield is not currently listed on the Pharmaceutical Benefits Scheme (PBS). Broader access to the therapy depends on PBS listing. Breakthrough T1D has stated it will advocate for this outcome.