{"id":6457,"date":"2022-11-18T14:57:43","date_gmt":"2022-11-18T14:57:43","guid":{"rendered":"https:\/\/www.breakthrought1d.org\/michigannoh\/?p=6457"},"modified":"2025-10-07T20:41:58","modified_gmt":"2025-10-07T20:41:58","slug":"fda-approves-tzield-a-watershed-moment-for-the-t1d-community","status":"publish","type":"post","link":"https:\/\/www.breakthrought1d.org\/southeastmi\/2022\/11\/18\/fda-approves-tzield-a-watershed-moment-for-the-t1d-community\/","title":{"rendered":"FDA Approves Tzield\u2122\u2014A Watershed Moment for the T1D Community"},"content":{"rendered":"

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Today, the U.S. Food and Drug Administration (FDA) weighed the evidence for teplizumab to delay type 1 diabetes (T1D) in at-risk individuals, and the T1D community got a big win:\u00a0Approved, under the brand name Tzield\u2122!<\/a>\u00a0Tzield (teplizumab-mzwv) is the\u00a0first<\/em>\u00a0disease-modifying therapy for individuals at-risk for developing T1D. (At-risk means that they exhibited 2+ T1D-related autoantibodies\u2014antibodies against one\u2019s own self\u2014and their blood glucose is starting to be abnormal, but they have not yet become insulin dependent.)<\/p>\n

For the first time in history, there is an approved therapy that addresses the autoimmunity behind T1D\u2014not just the symptoms that it causes in 1.4 million Americans.<\/p>\n

Aaron Kowalski, Ph.D., CEO of Breakthrough T1D, celebrated the decision\u2014the first approved therapy that can slow, halt, or reverse the course of the disease\u2014for T1D.<\/p>\n

\u201cA delay in the onset of type 1 diabetes will have a tremendous impact on the daily lives of people at risk for diabetes, their families, and the overall health system,\u201d said Dr. Kowalski. \u201cIt would free them from the constant burden and stress of blood-sugar monitoring and insulin administration. It would free them from the worry and fear of short- and long-term complications, while giving them the opportunity to learn more about disease management. That is clinically meaningful.\u201d<\/p>\n

Tzield can start to address the stark unmet need for disease-modifying therapies and provide people at-risk for T1D and their families at least without the burden and complications this disease brings. Tzield and multiple potential disease-modifying therapies that Breakthrough T1D has invested research into put us on the critical pathway to finding cures and, one day, preventing T1D entirely.<\/p>\n

Breakthrough T1D thanks the FDA for their thorough and thoughtful review of the evidence and data, showing that the benefits outweigh the risks to delay clinical T1D in at-risk individuals.<\/p>\n

What It Means for the Community<\/h4>\n

A delay in onset will be a gamechanger for at-risk individuals. Dr. Cory Wirt has experienced this firsthand. She 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.<\/p>\n

\u201cAs 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\u2019s independence with the importance of tight medical control,\u201d said Dr. Wirt. \u201cNot to mention the significant cost of supplies, office visits, and emotional stress.\u00a0We don\u2019t know how long the effects of the treatment will last, but every day without insulin has been a gift!\u201d<\/p>\n

Tracy Olsten is another parent who made the decision to enroll her daughter, Mikayla, in clinical trials for Tzield. \u201cWe know Mikayla has the biomarkers,\u201d said Olsten. \u201cWe know the probability is high that she will develop T1D in her life. But a little bit more time to live her teenage, young adult, and adult years without injections and finger pokes.\u201d<\/p>\n

A Day Decades in the Making<\/h4>\n

Today\u2019s decision would simply not have been possible without decades of Breakthrough T1D work, from funding discovery research to clinical development to work with regulators. Breakthrough T1D had a hand in the development of Tzield from the very beginning:<\/p>\n