Teplizumab Granted “Breakthrough” Designation for Delaying, Preventing Type 1 Diabetes

Biopharmeceutical company Provention Bio, Inc. has announced that its experimental medicine teplizumab has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the prevention or delay of type 1 diabetes in at-risk individuals.

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Teplizumab is a form of immunotherapy (a type of treatment that uses parts of a person’s own immune system to fight disease). Studies have shown that it can prolong insulin production in people recently diagnosed with type 1 diabetes and can significantly delay the onset of type 1 diabetes in high-risk individuals.

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BTD is an FDA program that expedites the development and review of treatments for serious or life-threatening conditions. To qualify for BTD, early evidence must indicate that the therapy may provide substantial improvement over currently available treatments.

“We are pleased that the FDA recognizes the transformative potential of PRV-031 in T1D, and we are committed to working with the Agency to bring this candidate to patients as quickly as possible,” said Ashleigh Palmer, CEO of Provention Bio. “The groundbreaking data from the ‘At Risk’ trial showed, for the first time, the potential to delay the onset of T1D in individuals who are almost certain to develop clinical disease. With this designation in place, we plan to leverage that landmark data, as well as the robust safety database from prior teplizumab studies, to support a registration filing. We look forward to discussing next steps with the FDA and providing an update on the process in the coming months.”

Want to learn more about teplizumab and type 1 diabetes? Read “Immunotherapy Delays Type 1 Diabetes Diagnosis: ADA 2019” and “Experimental Drug Teplizumab Delays Onset of Type 1 Diabetes: ADA 2019.”

Diane Fennell

Diane Fennell

Senior Digital Editor for DiabetesSelfManagement.com, Fennell has 16 years’ experience specializing in diabetes and related health conditions. Based in New York City, she has a degree from Columbia University.

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