OR WAIT null SECS
Tzield (teplizumab-mzwv) injection is the first FDA-approved therapy designed to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older.
FDA announced the approval of Provention Bio’s Tzield (teplizumab-mzwv) injection as a treatment for type 1 diabetes on Nov. 17, 2022. Teplizumab-mzwv is the first FDA-approved therapy designed to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older.
According to an agency press release, teplizumab-mzwv binds to certain immune system cells and delays the progression to stage 3 type 1 diabetes. It is designed to deactivate the immune cells that attack insulin-producing cells, increasing the proportion of cells that help moderate the immune response. The treatment is administered via intravenous infusion once daily over 14 consecutive days.
FDA based its approval on a randomized, double-blind, event-driven, placebo-controlled trial featuring 76 patients with stage 2 type 1 diabetes. Patients received either teplizumab-mzwv or a placebo once daily via intravenous infusion for 14 days. The primary efficacy measure was the time from randomization to the development of stage 3 type 1 diabetes. Of the patients who received teplizumab-mzwv, 45% were diagnosed with the condition over a median follow-up of 51 months versus 72% of those who received a placebo. Additionally, the mid-range time from randomization to stage 3 type 1 diabetes diagnosis was 50 months for the patients who received teplizumab-mzwv versus 25 months for those who received a placebo.
“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, FDA’s Center for Drug Evaluation and Research, in the release. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”