A monoclonal antibody was authorized by the Food and Drug Administration on Thursday for use in patients who have Stage 2 Type 1 diabetes, with an aim at delaying the onset of symptomatic Stage 3.
Teplizumab, marketed under the name Tzield, works by reprogramming the immune system to stop it from mistakenly attacking pancreatic cells which produce insulin.
The injectable drug is manufactured by ProventionBio and French drugmaker Sanofi.
According to ProventionBio, Tzield is for patients 8 or older with Stage 2 diabetes with two or more disease autoantibodies and abnormality in blood sugar stability.
According to the FDA, Tzield binds to certain immune system cells and delays progression to stage 3 type 1 diabetes. It also may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response.
“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, M.D., director of the Division of Diabetes, Lipid Disorders and Obesity in the FDA’s Center for Drug Evaluation and Research, said in a statement.
In aconference call Friday, ProventionBio said a 14-day course would cost $13,850 a vial, or about $194,000 wholesale.
Type 1 diabetes, previously known as juvenile diabetes, attacks the immune system and prevents the pancreas from making enough insulin. Insulin helps blood sugar enter the cells for use as energy.
In Stage 1, at least one diabetes-related autoantibody is present in the blood. In Stage 2, at least two or more of the autoantibodies are present. In Stage 3, symptoms are present, resulting in a diagnosis of Type 1 diabetes.
Globally, about 8.7 million people have Type 1 diabetes.
