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FDA Approves Insulin Inhalation Powder, Afrezza®

On June 27, 2014 the U.S. Food and Drug Administration (FDA) approved Afrezza, an insulin powder used to control blood sugar levels in patients with diabetes.

Data shows that approximately 25.8 million people in the United States, 8.3% of the population, have diabetes. Afrezza®, a rapid-acting insulin that is to be inhaled at the beginning of each meal, must be used in connection with long-acting insulin in patients with Type I Diabetes.

In a 24-week study, Afrezza® was evaluated for safety and effectiveness in 3,017 subjects – 1,026 participants with Type I Diabetes and 1,991 participants with Type II Diabetes. In adult patients with Type I Diabetes, mealtime Afrezza® was compared to mealtime insulin aspart (fast-acting insulin), both taken in combination with basal insulin (long-acting insulin). At week 24, treatment with mealtime Afrezza® and basal insulin provided an average reduction in HbA1c (hemoglobin A1c or glycosylated hemoglobin), a measure in blood sugar control, that met the pre-specified non-inferiority margin of 0.4 percent, which was not found in participants using insulin aspart. During the same 24-week study, mealtime Afrezza® was compared to a placebo inhalation, both in combination with oral antidiabetic drugs, in patients with Type II Diabetes. At week 24, treatment with mealtime Afrezza® and oral antidiabetic drugs showed an average reduction in HbA1c that was substantially greater than that of the placebo group.


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