TGA approves treatment delaying clinical type 1 diabetes onset

In what is being described as a ‘transformational moment’, a new treatment has been approved to delay the onset of clinical type 1 diabetes.

The Therapeutic Goods Administration (TGA) has approved teplizumab (sold as Tzield) to ‘delay the onset of stage 3 type 1 diabetes in adult and paediatric patients aged eight years and older with stage 2 type 1 diabetes’.
 
The therapy works by targeting the immune attack that causes type 1 diabetes, delaying progression to clinical diagnosis by an average of two years.
 
Tzield is not currently listed on the Pharmaceutical Benefits Scheme, but its manufacturer confirmed a funding submission will be considered by the Pharmaceutical Benefits Advisory Committee at its July meeting.
 
It says the TGA’s decision marks the first new therapy approved for type 1 diabetes in more than a century, since the discovery of insulin, and the first therapy to delay onset.
 
RACGP Specific Interests Diabetes Chair Dr Gary Deed welcomes the approval, saying the treatment allows for ‘active surveillance, active intervention, and delay in progression’.
 
‘Type 1 diabetes can be quite devastating, not only just to the person, but their carers, and their parents,’ he told newsGP.
 
‘A delay allows them access to specialist teams, psychosocial support, closer health surveillance that is focused on preparing them, but also preventing a disastrous medical emergency.’
 
More than 145,000 Australians are living with type 1 diabetes, but an estimated 25,000 are unknowingly living with the early stages of the condition.
 
Screening is currently the only way to identify people eligible for teplizumab before symptoms develop.
 
Breakthrough T1D Chief Executive Officer Sydney Yovic said the approval highlights why this screening for early-stage type 1 diabetes is important.
 
‘For generations, type 1 diabetes has only been treated once symptoms appear and insulin therapy becomes essential – Tzield changes that,’ she said.
 
‘Delaying progression means more time without insulin therapy, glucose monitoring, fear of severe hypoglycaemia and the constant decision-making that comes with type 1 diabetes.
 
‘Tzield can only be beneficial if people are detected in the early stages, before symptoms develop, creating a critical opportunity to intervene earlier and improve long-term health outcomes.’
 
The approval comes after almost 40 years of screening research, with Breakthrough T1D’s first funded research into teplizumab taking place in 1988.
 
Dr Deed said with screening now more important than ever, the change is a reminder of the central role of GPs in diabetes care.
 
‘Identifying people at risk by targeted antibody screening also allows us to identify these people at heightened risk so we can prepare family and the person, who might be a child, who might be an adult, for what are the red flags,’ he said.

‘Sometimes things that don’t occur frequently should not be overlooked, and a prepared GP, a knowledgeable GP, is an asset in this whole process.
 
‘This is a reminder again of placing general practice back into early intervention, early assessment, and patient support.’
 
Tzield is already approved for use around the world, including in the European Union, the United States, the United Kingdom, China and Canada.
 
Log in below to join the conversation.

diabetes teplizumab type 1 diabetes Tzield