1st drug to delay the onset of Type 1 diabetes approved by FDA ?
On Thursday , the Food and Drug Administration approved the first drug that will delay the onset Type 1 diabetes.
Tzield is a monoclonal anti-body injection. It is approved for Type 1 diabetics aged 8 years and older.
According to the American Diabetes Association, nearly 2 million Americans have Type 1 Diabetes. Although symptoms can occur at any age, it is most commonly diagnosed in children and young people.
Type 1 diabetes is characterized by a lack of insulin production. Insulin is a hormone that tells cells to use sugar in the bloodstream for energy. Too much sugar in the blood can cause health problems.
Sanofi and Provention Bio have developed a new drug that prevents the body’s immune system mistakingly attacking insulin-producing cells.
FDA stated that its approval was based upon a phase 2 clinical study in which 76 people were randomly assigned to receive either the drug or a placebo intravenously once daily for 14 days. The trial participants had Type 1 diabetes, an early stage of which blood sugar levels were abnormal but symptoms are still developing.
The median time it took to diagnose patients who received the drug was approximately four years. This compares to the two-year average for those in the placebo group.
The American Diabetes Association described the approval as an “historic moment” that will benefit all those affected by the condition.
