The FDA announced the approval of Afrezza (insulin human; MannKind Corporation) Inhalation Powder for the improvement of glycemic control in adults with diabetes mellitus. Afrezza Inhalation Powder is a rapid-acting inhaled insulin administered at the beginning of each meal or within 20 minutes of starting a meal. In patients with type 1 diabetes, Afrezza Inhalation Powder must be taken with a long-acting insulin.
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.
RELATED: Afrezza, Inhaled Insulin, NDA Resubmitted to FDA
The FDA approved Afrezza with a Risk Evaluation and Mitigation Strategy (REMS) and has required the following post-marketing studies:
- A clinical trial to evaluate pharmacokinetics, safety and efficacy in pediatric patients
- A clinical trial to evaluate the potential risk of pulmonary malignancy with Afrezza
- Two pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, one to characterize dose-response and one to characterize within-subject variability
Afrezza Inhalation Powder will be available as 4 unit and 8 unit single-use cartridges in various 60- and 90-count packaging including 2 inhalers.
For more information call (877) 323-8505 or visit Afrezza.com.