JDRF Celebrates Tzield™ (teplizumab-mzwv) Approval

A Significant Milestone for the Type 1 Diabetes Community 

Tzield™ (teplizumab-mzwv), a First of its Kind Drug can Delay the Onset of Type 1 Diabetes in At-Risk Individuals 

NEW YORK, Nov. 17, 2022 /PRNewswire/ -- JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization, applauds today's decision from the U.S Food and Drug Administration to approve Provention Bio's Tzield™ (teplizumab-mzwv). Tzield is the first disease-modifying therapy available to delay clinical T1D in people at risk of developing the disease. Studies have shown Tzield can delay the onset of T1D for approximately 2 years. 

"Today's FDA decision gives people at risk of developing type 1 diabetes the gift of time," said Aaron Kowalski, Ph.D., JDRF CEO. "For the first time ever, we have a way to 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 contribute 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 Tzield is accessible to those who need it. 

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, Tzield will allow those with biomarkers to postpone the disease burden and reduce the risks of eye, kidney, nerve, and heart disease—complications frequently associated with T1D. Tzield's approval can mean additional years without the emotional weight of blood-sugar monitoring and insulin administration. It also gives families time to prepare for a future diagnosis.  

"How fitting for this news to be announced in November, National Diabetes Awareness Month," said Sanjoy Dutta, Ph.D., JDRF's chief scientific officer. "JDRF's theme for the month is 'Forward' highlighting the progress made by the T1D community and the work to come. Investing in Tzield, the first disease-modifying therapy for T1D, is just one example of how JDRF is advancing type 1 diabetes research and the search for cures 'Forward.'"  

Dr. Cory Wirt enrolled her daughter, Claire, who had biomarkers and was at risk for developing T1D, in a clinical trial for Tzield 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. 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 work, beginning with 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.  

Dr. Kevan Herold from Yale School of Medicine is one of the clinical investigators who began this research. "The story with the clinical use of teplizumab began with a JDRF grant to support a trial in patients with new onset type 1 diabetes more than two decades ago," said Dr. Herold. "The success of this initial study planted a seed that led to further studies and support from the National Institutes of Health (NIH)." 

"The recent decision represents a turning point in the field. First, it identifies a way in which an immune therapy to stop the disease process might be combined with cell replacements in those with type 1 diabetes. It also suggests that it is time to more broadly screen to identify those at risk for type 1 diabetes, since now there is a therapy that can change its course." 

About JDRF 

JDRF's mission is to accelerate life-changing breakthroughs to cure, prevent, and treat type 1 diabetes (T1D) and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally and globally for efficiency and broader fundraising impact, and uniting on a global stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States, around the world, and at our five international affiliates are dedicated to advocacy, community engagement, and a shared vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter (@JDRF), Facebook (@myjdrf), and Instagram (@jdrfhq). 

About Type 1 Diabetes (T1D) 

T1D is an autoimmune condition that causes the pancreas to make very little insulin or none at all. This leads to dependence on insulin therapy and the risk of short or 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. Globally, it impacts nearly 9 million people. Many believe T1D is only diagnosed in childhood and adolescence, but diagnosis in adulthood is common and accounts for nearly 50% of all T1D diagnoses. The onset of T1D has nothing to do with 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. 

SOURCE JDRF