Washington: US authorities have approved a fast-acting inhaled insulin to improve glycemic control in adults with diabetes.
The drug Afrezza Inhalation Powder is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal.
Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness and nerve and kidney damage.
"Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin," said Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research.
The "approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels," said Guettier.
The drug's safety and effectiveness were evaluated in a total of 3,017 participants - 1,026 participants with type 1 diabetes and 1,991 patients with type 2 diabetes.
The efficacy of mealtime Afrezza in adult patients with type 1 diabetes patients was compared to mealtime insulin aspart (fast-acting insulin), both in combination with basal insulin (long-acting insulin) in a 24 week study.
At week 24, treatment with basal insulin and mealtime Afrezza provided a mean reduction in HbA1c (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control) that met the pre-specified non-inferiority margin of 0.4 per cent.
Afrezza provided less HbA1c reduction than insulin aspart, and the difference was statistically significant.
Afrezza was studied in adults with type 2 diabetes in combination with oral antidiabetic drugs; the efficacy of mealtime Afrezza in type 2 diabetes patients was compared to placebo inhalation in a 24 week study.
At week 24, treatment with Afrezza plus oral anti-diabetic drugs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group.
Afrezza is not a substitute for long-acting insulin. It must be used in combination with long-acting insulin in patients with type 1 diabetes, and it is not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke.