Sanofi and MannKind announced that Afrezza (insulin human) Inhalation Powder is now available to improve glycemic control in adults with type 1 and type 2 diabetes. Afrezza is the only inhaled insulin currently available, and is indicated for use as part of a diabetes management plan that may include diet, exercise, and other diabetes treatments.
Afrezza consists of a rapid-acting human insulin in a dry formulation that is administered from a small inhaler. It is quickly absorbed and has a short duration of action. Insulin lowers blood glucose levels by stimulating peripheral glucose uptake by skeletal muscles and fat, and by inhibiting hepatic glucose production. Insulin also inhibit lipolysis in adipocytes, inhibits proteolysis, and enhances protein synthesis.
The safety and efficacy of Afrezza were studied in 1,026 patients with type 1 diabetes and 1,991 patients with type 2 diabetes. The efficacy of mealtime Afrezza in type 1 diabetes patients was compared to mealtime insulin aspart, both in combination with basal insulin in a 24-week study. At Week 24, treatment with basal insulin and mealtime Afrezza showed a mean reduction in HbA1c that met the non-inferiority margin of 0.4%. Afrezza provided a statistically significant less HbA1c reduction than insulin aspart.
Afrezza was also evaluated 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 in combination with oral antidiabetic drugs provided a mean reduction in HbA1c that was statistically significantly greater vs. the HbA1c reduction seen 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.
Afrezza has a Boxed Warning advising that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD). It should not be used in patients with chronic lung disease, such as asthma or COPD because of this risk.
Afrezza Inhalation Powder is available as four and eight unit single-use cartridges in various 30-, 60-, and 90-count packages along with two inhalers. The disposable inhaler may be used for up to 15 days.
For more information call (800) 633-1610 or visit Afrezza.com.