The first new therapy for type 1 diabetes (T1D) since the discovery of insulin more than a century ago has been approved for use in Australia.
Research organisation Breakthrough T1D Australia announced today that Tzield was now available as a treatment.
Tzield is used to delay the onset of stage 3 (or clinical) T1D – where changes in blood glucose levels have begun but insulin therapy is not yet required.
More than 145,000 Australians are currently living with T1D, and an estimated 25,000 people are unknowingly living with the early stages of the condition.
Breakthrough T1D said in a statement that the Tzield therapy worked by targeting the “immune attack” that caused T1D, delaying progression to clinical diagnosis by an average of two years.
It said the approval of Tzield (teplizumab) by the Therapeutic Goods Administration (TGA) marked the first therapy available to delay the onset of clinical T1D.
“The landmark approval is a historic moment for the T1D community and the culmination of almost four decades of research funding, advocacy and strategic investment by Breakthrough T1D, the leading non-profit organisation for T1D globally,” the statement said.
“Their support has played a central role in the development of the therapy, from its earliest stages through to clinical trials, screening initiatives and global advocacy efforts.”
Tzield is available for people aged eight years and older with stage 2 T1D – the early, pre-symptomatic stage of the condition, where changes in blood glucose levels have begun but insulin therapy is not yet required.
“The therapy works by targeting the immune attack that causes T1D, delaying progression to clinical diagnosis by an average of two years,” Breakthrough T1D said.
“This gives people valuable time without the daily burden of insulin therapy and glucose monitoring.
“It is the first new therapy approved for T1D in more than 100 years – since the discovery of insulin – and represents a major shift in how the condition can be approached, from treating T1D after diagnosis to delaying its progression before symptoms develop.”
Breakthrough T1D Australia Chief Executive Officer, Sydney Yovic, said the approval represented a transformational moment for Australians affected by T1D.
“For generations, T1D has only been treated once symptoms appear and insulin therapy becomes essential,” he said.
“Tzield changes that. For the first time, we can intervene earlier in the disease process and delay the onset of stage 3 T1D.”
Ms Yovic said the approval highlighted why screening for early-stage T1D was so important.
She said Tzield could only be beneficial if people were detected in the early stages, before symptoms developed, creating a critical opportunity to intervene earlier and improve long-term health outcomes.
Broader access to Tzield will depend on listing on the Pharmaceutical Benefits Scheme (PBS). Breakthrough T1D is advocating for that.
Professor John Wentworth, an Endocrinologist and Senior Clinical Research Fellow at St Vincent’s Institute of Medical Research, said the approval of Tzield was an exciting and important development.
“In recent years, there has been a giant leap forward in scientific understanding of type 1 diabetes, enabling meaningful progress for both its diagnosis and treatment,” he said.
“This represents an entirely new approach to the treatment of this condition as it is now possible to detect and treat type 1 diabetes before symptoms present.”
Country Lead for biopharma company Sanofi (Australia and New Zealand), Liz Selby, said diabetes was a key focus for Sanofi.
“We are pleased that, for the first time, we are able to offer patients and families in Australia a disease-modifying therapy designed to address the underlying immune process of type 1 diabetes,” she said.
“We will continue to work closely with researchers, advocates, clinicians, policymakers and the community to advance science to help those living with type 1 diabetes and their families.”
More information is available here
