JDRF celebrates approval of Tzield™ (teplizumab-mzwv).

A significant milestone for the type 1 diabetes community

Tzield (teplizumab-mzwv)a first-of-its-kind drug could delay the onset of type 1 diabetes in people at risk

NEW YORK, November 17, 2022 /PRNewswire/ — JDRF, the world’s leading research and advocacy organization for type 1 diabetes (T1D), applauds today’s decision by 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 that Tzield can delay the onset of T1D by about 2 years.

“Today’s FDA decision gives people at risk of developing type 1 diabetes a gift of time,” he said Aaron Kowalski, Ph.D., Director General of JDRF. “For the first time, we have a way to change course and slow down the development of T1D. This is a huge win for the T1D community and the latest example of how JDRF research and advocacy is helping to improve lives today and tomorrow. I am extremely proud of the role JDRF has played in bringing this therapy to market and we look forward to working with other stakeholders to ensure that Tzield is available to those who need it.

There are many responsible for this achievement, and JDRF expresses our deepest gratitude to all involved – the many brilliant scientists including Dr. Jeffrey Bluestone, Dr. Lucienne Chatenoud, MD, and Kevan HeroldMD, the National Institutes of Health (NIH), clinical trial participants, and Provention Bio for making today a reality.”

By delaying the onset of T1D, Tzield will enable those with biomarkers to postpone the disease burden and reduce their risk of eye, kidney, nerve and heart diseases – complications often associated with T1D. Tzield’s approval could mean extra years without the emotional burden of monitoring blood sugar and administering insulin. It also gives families time to prepare for a future diagnosis.

“It’s good that this news was announced in November, National Diabetes Awareness Month,” he said. Sanjoy Dutt, Ph.D., chief science officer of the JDRF. “JDRF’s theme for the month is ‘Forward’, highlighting the progress made by the T1D community and future work. 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 “Forward” cures.

Dr. Cory Wirt enrolled her daughter, Claire, who had biomarkers and was at risk of developing T1D, into a clinical trial for Tzield 7 years ago. She has not yet reached the clinical stage of T1D.

“As a mom, I appreciate 83 months of not checking my blood sugar several times a day, worrying about life-threatening dips, and balancing my child/teen’s independence with the importance of close medical supervision,” said Dr. Wirt. “Not to mention significant procurement costs, 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 JDRF’s decades of work, beginning with basic research in the 1980s. JDRF’s commitment culminated in JDRF’s strategic investment T1D in 2017, bringing Provention Bio to T1D for the first time.

Dr. Kevan Herold With Yale Medical School is one of the clinical investigators who started this research. “The history of the clinical use of teplizumab began more than two decades ago with a JDRF grant to support a study in patients newly diagnosed with type 1 diabetes,” said Dr. Herold. “The success of this initial study planted a seed that led to further research and support from the National Institutes of Health (NIH).”

“The recent decision marks a turning point in this area. First, it identifies how immune therapy to stop the disease process may be combined with cell replacement in people with type 1 diabetes. It also suggests that it is time for more extensive screening to identify people at risk for type 1 diabetes, because there is now a therapy that can change its course.”

About JDRF

JDRF’s mission is to accelerate life-changing breakthroughs in the treatment, prevention and treatment of Type 1 Diabetes (T1D) and its complications. To achieve this, JDRF has invested over $2.5 billion in funding research since the beginning of our existence. We are an organization built on a grassroots model of people connecting in local communities, collaborating regionally and globally to increase the efficiency and wider impact of fundraising, and uniting on the global stage to pool resources, passion and energy. We work with academic institutions, policy makers, and corporate and industrial partners to develop and deliver a range of innovative therapies to people living with T1D. Our staff and volunteers all the time United States, around the world and in our five international offices are dedicated to advocacy, community engagement and a shared vision for a world without T1D. For more information, visit jdrf.org or follow us on Twitter (@JDRF), Facebook (@myjdrf) and Instagram (@jdrfhq).

About type 1 diabetes (T1D)

T1D is an autoimmune disease that causes the pancreas to produce very little or no insulin. This leads to dependence on insulin therapy and the risk of short or long-term complications, which may include spikes and drops in blood sugar levels; damage to the kidneys, eyes, nerves and heart; and even death if left untreated. Worldwide, it affects nearly 9 million people. Many believe that T1D is only diagnosed in childhood and adolescence, but diagnosis in adulthood is common, accounting for nearly 50% of all T1D diagnoses. The onset of T1D has nothing to do with diet or lifestyle. Although its causes are not yet fully understood, scientists believe that both genetic and environmental factors are involved. There is currently no cure for T1D.



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