Provention Bio receives FDA nod for Tzield
Provention Bio has obtained the Food and Drug Administration’s green light for Tzield (teplizumab-mzwv), an anti-CD3-directed antibody, for intravenous use, as the first and only immunomodulatory treatment to delay the onset of stage 3 type 1 diabetes in adult and pediatric patients aged 8 years old and older with stage 2 type 1 diabetes.
"This is a historic occasion for the T1D community and a paradigm shifting breakthrough for individuals aged 8 years and older with stage 2 T1D who now have a therapy approved by the FDA to delay the onset of stage 3 disease. It cannot be emphasized enough how precious a delay in the onset of stage 3 T1D can be from a patient and family perspective; more time to live without and, when necessary, prepare for the burdens, complications and risks associated with Stage 3 disease," said Ashleigh Palmer, co-founder and CEO of Provention Bio.
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Palmer added, "We would especially like to acknowledge and thank all the researchers, scientists, developers and investigators, especially TrialNet and NIDDK; all the clinical trial participants and their families; the FDA and its reviewers; and JDRF and other patient advocacy groups and champions who have, over more than two decades, tirelessly and selflessly contributed to the development and approval of this first and only therapy to address the underlying autoimmunity of T1D, thereby fundamentally changing the course of the disease rather than just treating its symptoms."
"Today's approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients," said John Sharretts, director of the division of diabetes, lipid disorders, and obesity in the FDA's Center for Drug Evaluation and Research. "The drug's potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease."
Tzield binds to certain immune system cells and delays progression to stage 3 type 1 diabetes. Tzield may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response. Tzield is administered by intravenous infusion once daily for 14 consecutive days, the FDA said.
In October 2022 the company announced a co-promotion agreement for the U.S. launch of Tzield for the delay in the onset of clinical T1D in at-risk individuals with Sanofi.
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Olivier Bogillot, head of U.S. general medicines of Sanofi, said, "This approval is a profound and long-awaited victory for the diabetes community. We applaud Provention Bio for its unwavering determination to bring the first ever disease-modifying therapy for T1D to patients. We look forward to leveraging Sanofi's established infrastructure and expertise in endocrinology to deliver for individuals in need across the United States."