The FDA has approved treatment to delay the onset of Type 1 diabetes for the first time.
Pharmaceutical companies ProventionBio and Sanofi will market teplizumab under the brand name Tzield, an intravenous infusion of a monoclonal antibody.
In clinical trials, the injection was shown to delay insulin-dependent Type 1 diabetes onset by over two years in patients with autoantibody markers of early risk, with the possibility of postponing it even longer in some cases.
"Today's approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients," said Dr. John Sharretts at 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."
Children and adults with stage 2 Type 1 diabetes who take Tzield can delay the onset of stage 3 diabetes.
As a result, people can stay away from pharmaceutical insulin for an extended period because the medication slows down the body's attack on its insulin-producing cells.
Tzield is not recommended for patients with type 2 diabetes, pre-Type two diabetes, or insulin-dependent Type 1 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."
A person with type 1 diabetes cannot produce insulin, the hormone responsible for controlling blood sugar levels in the body.
People with Type 1 diabetes must take insulin shots or wear an insulin pump to survive because their blood glucose levels are elevated.
According to the U.S. Centers for Disease Control and Prevention, more than 64,000 people are diagnosed with insulin-dependent Type 1 diabetes nationwide each year.
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