In a win for Red Bank, N.J.-based ProventionBio, the FDA approved its drug Tzield Nov. 17, marking the first approved therapy to delay the onset of Type 1 diabetes.
Tzield (teplizumab-mzwv) is approved for patients 8 years and older who currently have stage 2 Type 1 diabetes. In a trial of 76 patients with stage 2 type 1 diabetes, 45 percent of patients who received the injection later developed stage 3 compared to 72 percent of patients who received the placebo, according to the FDA.
"The drug's potential to delay clinical diagnosis of Type 1 diabetes may provide patients with months to years without the burdens of disease," John Sharretts, MD, director of the FDA's division of diabetes, lipid disorders and obesity, said in a statement.
Type 1 and Type 2 diabetes, a chronic disease in which the body cannot produce enough insulin, were the direct cause of 1.5 million deaths in 2019, according to the World Health Organization.