Tzield is the first TGA-approved treatment for type 1 diabetes since the discovery of insulin more than 100 years ago and is the first medication approved in Australia to change the course of type 1 diabetes, rather than just managing it, writes ZOE DELEUIL.
Tzield, also known as teplizumab, has been approved by the Therapeutic Goods Administration (TGA) for people aged eight and older with early type 1 diabetes.
Type 1 diabetes is an autoimmune condition where the person’s own immune system attacks insulin-producing cells in the pancreas. Insulin is an essential hormone for life, and once this autoimmune destruction has happened, a person is often diagnosed in hospital in an acute condition, known as ketoacidosis, due to dangerously high glucose levels.
In early type 1 diabetes, blood glucose levels have started to rise and antibodies are present but symptoms have not yet appeared, and glucose levels are likely unaffected.
Teplizumab works as an immune modulator – it stops the autoreactive T cells that can destroy the pancreas cells and turns on the regulatory T cells that can protect them.
For people who are diagnosed with early type 1 diabetes through early screening, delaying onset with Tzield can give them valuable time to prepare themselves for managing the condition. Earlier diagnosis and monitoring preserves insulin-producing cells (pancreatic beta-cells) for longer and reduces the risk of ketoacidosis and its associated complications.
Prior to this, treatment only began when people needed insulin therapy. By reducing the immune attack, a single 14-day course of teplizumab can delay the onset of type 1 diabetes by an average of two to three years.
This delay can provide vital time to prepare, for very young children to grow, and can make the condition easier to manage in the future. Early warning and preparation means type 1 diabetes can be recognised earlier, before it progresses to ketoacidosis.
Dr Dorota Pawlak, chief scientific officer at Breakthrough T1D, who developed the treatment, says teplizumad has the potential to transform type 1 diabetes care in Australia.
“Despite significant improvements in management, type 1 diabetes is a relentless, 24/7 condition, and every day lived without it matters. Breakthrough T1D is proud to have supported decades of research to develop and test Tzield, as well as major advocacy efforts to raise awareness of its importance. This is so important for our community, and we welcome Tzield’s TGA listing with open arms.”
This approval also highlights the importance of early screening. Australia has one of the highest rates of type 1 diabetes in the world, with more than 145,000 Australians living with the condition and an estimated 25,000 more who may be in the early stages without knowing it.
Identifying those people is the only way they can be considered for treatments like Tzield. Type1Screen is a free and easy screening process for Australians who already have a family member diagnosed with type 1 diabetes, as they have a higher risk of developing the condition compared to the general population.
Professor John Wentworth (pictured above), an endocrinologist and Senior Clinical Research Fellow at St Vincent’s Institute of Medical Research, said the development represents a new and more effective way to treat type 1 diabetes. After decades of work by researchers, clinicians and the diabetes community, he says Australia now has the opportunity to detect and treat the condition before symptoms begin.
“This is a wonderful development, a watershed moment that validates what we’ve been doing for the last 30 years,” says Professor Wentworth. “Early diagnosis through screening can not only give people the information they need to prepare for type 1 diabetes, it also means we can delay the need to use insulin and give people a brighter future. This will change the way we think about type 1 diabetes.”
There is still one important step ahead. While TGA approval clears the way for use in Australia through compassionate access or clinical trials, accessible and affordable access will depend on whether Tzield is listed on the Pharmaceutical Benefits Scheme, or PBS. The PBS advisory committee will consider a funding submission from manufacturer Sanofi when it meets in July.
Diabetes WA is very excited about what this news means for the future of screening and treatment for type 1 diabetes.
“TGA approval is an amazing first step towards bringing new treatment options for type 1 diabetes. Now we need to see whether this can be funded under the PBS before we can really see this new treatment changing the lives of Australians with early type 1 diabetes,” says Jessica Weiss, pharmacist and diabetes educator at Diabetes WA.
Do you have any questions about early screening for type 1 diabetes? Call our Helpline on 1300 001 880 or visit Type1Screen, where you can access free and easy screening for type 1 diabetes.
