Afrezza (insulin human) Inhalation Powder

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved June 2014

Specific Treatments:

diabetes mellitus

Therapeutic Areas

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General Information

Afrezza is a rapid acting inhaled insulin powder. When the insulin is inhaled through the device, the powder is aerosolized and delivered to the lung.

Afrezza is specifically indicated to improve glycemic control in adult patients with diabetes mellitus.

Limitations of Use: Afrezza is not a substitute for long-acting insulin. Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus. Afrezza is not recommended for the treatment of diabetic ketoacidosis.

Afrezza is supplied as a powder to be administered via oral inhalation. Afrezza should be administered at each mealtime. For specific dose requirements and dose adjustments, refer to the Afrezza drug label.

Clinical Results

FDA Approval

The FDA approval of Afrezza was based on the following trial results:

Type I diabetes:

 A 24-week, open-label, active-controlled study enrolled 344 subjects inadequately controlled type 1 diabetes to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin. Following a 4-week basal insulin optimization period, subjects were randomized to Afrezza (n=174) or insulin aspart (n=170)administered at each meal of the day. Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study. At Week 24, treatment with basal insulin and mealtime Afrezza provided a mean reduction in HbA1c that met the pre-specified requirement for non-inferiority margin of 0.4%. Afrezza provided less HbA1c reduction than insulin aspart, and the difference was statistically significant. More subjects in the insulin aspart group achieved the HbA1c target of ≤7%.

Type II diabetes:

A total of 479 adult patients with type 2 diabetes inadequately controlled on optimal/maximally tolerated doses of metformin only, or 2 or more oral antidiabetic (OAD) agents participated in a 24-week, double-blind, placebo-controlled study. Following a 6-week run-in period, 353 patients were randomized to Afrezza (n=177) or an inhaled placebo powder without insulin (n=176). Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study. OADs doses were kept stable. At Week 24, treatment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group.

Side Effects

Adverse effects associated with the use of Afrezza may include, but are not limited to, the following:

hypoglycemia

cough

throat pain

irritation

Afrezza carries a risk of acute bronchospasm in patients with chronic lung disease

Mechanism of Action

Afrezza is a rapid acting inhaled insulin powder. When the insulin is inhaled through the device, the powder is aerosolized and delivered to the lung. Insulin lowers blood glucose levels by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in adipocytes, inhibits proteolysis, and enhances protein synthesis.

Additional Information

For additional information regarding Afrezza or type I and II diabetes, please visit www.afrezza.com