FDA approves teplizumab to delay type 1 diabetes in at-risk individuals in US 

In a world-first, a disease modifying therapy has been approved for people living with the condition  

JDRF and the T1D community are today celebrating a decision from the U.S Food and Drug Administration (FDA) to approve Provention Bio’s teplizumab for people at risk of T1D in the U.S.  

Studies have shown the drug can delay the onset of stage 3 type 1 diabetes (T1D), known as clinical T1D, for months to up to two years in adults and paediatric patients 8 years and older who currently have stage 2 type 1 diabetes (when individuals do not have clinical symptoms of T1D, but show signs of autoimmune attack and loss of insulin producing cells).  

This is the first disease modifying therapy (DMT) approved for the condition in history.  

Teplizumab is an immunotherapy drug that binds to certain immune system cells and may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response. It is administered by intravenous infusion once daily for 14 consecutive days. 

Aaron Kowalski, Ph.D., JDRF International CEO, says that “this decision gives people at-risk of developing type 1 diabetes the gift of time. For the first time ever, we have a way to change the course and slow the development of type 1 diabetes.  

“This is a huge win for the community and the latest example of how JDRF’s research and advocacy contributes to improving lives today and tomorrow. I am tremendously proud of the role JDRF played in bringing this therapy to market, and we look forward to working with other stakeholders to ensure teplizumab is accessible to those who need it.”  

This decision comes off the back of decades of JDRF work and investment in the research, beginning with early-stage research in the 1980s and additional funding as recently as 2017.  

According to Dr Dorota Pawlak, Chief Scientific Officer of JDRF Australia, “delaying the onset of T1D with teplizumab will allow those with biomarkers to postpone the significant burden this condition brings and give families time to prepare for a future diagnosis.  

“Teplizumab’s approval can mean additional years without the emotional weight of blood-sugar monitoring and insulin administration, and we know the for the type 1 diabetes community, every day without the condition matters.”  

Mike Wilson OAM, CEO of JDRF Australia, says that “This is incredibly exciting news, and a great moment for the T1D community globally. We look forward to working with our international JDRF colleagues, alongside researchers and pharmaceutical partners, to bring this progress to Australia as soon as possible.”  

To read more about Teplizumab and the FDA’s decision, read their announcement here.  

For more information about JDRF U.S and what this means for their T1D community, visit their website.  

-ENDS-