JDRF and its affiliates celebrate Teplizumab approval

This is a significant milestone for the type 1 diabetes community as teplizumab is the first drug that can delay the onset of type 1 diabetes in at-risk individuals

Toronto, November 17, 2022 — JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization, applauds today’s decision from the U.S Food and Drug Administration (FDA) to approve Provention Bio’s teplizumab. Teplizumab is the first therapy available to delay the onset of clinical T1D in people at-risk of developing the disease.

“Today’s decision by the US FDA represents the first disease-modifying therapy to be approved for T1D in any country,” said Dr. Sarah Linklater, Chief Scientific Officer for JDRF Canada. “Teplizumab can change the course and slow the development of T1D. This is a huge win for the T1D community and the latest example of how JDRF’s research and advocacy contributes to improving the lives of people and families affected by the disease. We will continue to prioritize research into T1D risk screening and prevention. Weare so proud of JDRF’s role in bringing this therapy to the T1D community, and we look forward to working to ensure teplizumab now becomes available to those who need it in Canada.”

There are many responsible for this accomplishment, and JDRF extends our deepest gratitude to all involved – many brilliant researchers including Jeffrey Bluestone, Ph.D., Lucienne Chatenoud, M.D., Ph.D., and Kevan Herold, M.D., the National Institutes of Health (NIH), the clinical trial participants, and Provention Bio for making today a reality.”

By delaying the onset of T1D, teplizumab will allow those at high risk of developing the disease to postpone the disease burden and reduce the risks of eye, kidney, nerve and heart disease–complications frequently associated with T1D. Teplizumab’s approval can mean additional years without the burden of blood glucose monitoring and insulin administration. It also gives families time to prepare for a future diagnosis.

“November is National Diabetes Awareness Month, so the timing of this approval is incredible,” said Dave Prowten, President and CEO of JDRF Canada. “JDRF’s theme for the month is sharing the realities of what living with T1D means on a daily basis – the time lost to managing blood glucose, recovering from a hypoglycemic episode, hours of lost sleep. By now having a drug that can delay the onset of this disease, potentially by several years, people can get some of that time back.”

Dr. Cory Wirt enrolled her daughter, Claire, who had biomarkers and was at-risk for developing T1D, in a clinical trial for teplizumab 7 years ago. Today, she has yet to progress into clinical T1D.

“As a mom, I appreciate 83 months of not checking blood-sugars multiple times per day, worrying about life threatening lows, and balancing my child/teen’s independence with the importance of tight medical control,” said Dr. Cory Wirt. “Not to mention the significant cost of supplies, office visits, and emotional stress.  We don’t know how long the effects of the treatment will last, but every day without insulin has been a gift!”

Today’s decision would not have been possible without decades of JDRF support, beginning with funding of basic research in the 1980s. JDRF’s involvement culminated in a strategic investment by the JDRF T1D Fund in 2017 that brought Provention Bio into T1D for the first time.  

Currently, teplizumab has only been approved by the FDA for use in the United States. It is our hope that it will be reviewed by Health Canada in the near future for use in Canada.

About JDRF Canada

JDRF Canada is the leading charitable organization funding type 1 diabetes (T1D) research in Canada. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. Since our founding in 1974, JDRF has invested more than $80 million CDN in research funding. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, governments, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout Canada and five international affiliates are dedicated to advocacy, community engagement and our shared vision of a world without T1D. For more information, please visit jdrf.ca.  

About Type 1 Diabetes (T1D)

T1D is an autoimmune condition that causes the pancreas to make very little insulin or none at all, leading to long-term complications which can include highs and lows in blood-sugar; damage to the kidneys, eyes, nerves and heart; and even death if left untreated. It is one of the fastest-growing chronic health conditions. Many believe T1D is only diagnosed in childhood and early puberty, but diagnosis in adulthood is on the rise, and accounts for nearly 50% of all T1D diagnoses. The onset is sudden and nothing can be done to prevent it yet—it is not related to diet or lifestyle. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. There is currently no cure for T1D.

Stay connected on the latest