FDA Approves a Treatment that Delays Onset of Type 1 Diabetes

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FDA Approves a Treatment that Delays Onset of Type 1 Diabetes


Teplizumab, a monoclonal antibody that will be marketed under the brand name Tzield from pharmaceutical companies ProventionBio and Sanofi, is administered through intravenous infusion. The injection was shown in clinical trials to delay onset of insulin-dependent Type 1 diabetes for patients with autoantibody markers of early risk by over two years, with hopes for some that it can delay onset even longer.... Tzield was approved to delay the onset of stage 3 Type 1 diabetes in adults and children ages 8 and up who currently have stage 2 Type 1 diabetes.

The medication is thought to slow down the body's attack on its own insulin-producing cells and thus give people more time before they become dependent on pharmaceutical insulin. Tzield is not suitable for people with insulin-dependent Type 1 diabetes, people who are pre-Type 2 diabetics or those with type 2 diabetes. "This approval is a watershed moment for the treatment and prevention of type 1 diabetes," said Dr. Mark S. Anderson, director of the University of California San Francisco Diabetes Center. "Until now, the only real therapy for patients has been a lifetime of insulin replacement. This new therapy targets and helps to halt the autoimmune process that leads to the loss of insulin...."

Studies have shown that 75% of people with these diagnostic markers usually become insulin-dependent within five years and nearly 100% at some point in their lifetime.
 
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