Afrezza insulin inhalation powder has now been approved by the U.S. Food and Drug Administration. Afrezza (pronounced uh-FREZZ-uh) is a fast acting inhaled insulin adults with diabetes mellitus, that is taken at the beginning of meals, or within 20 minutes after beginning meals.
“Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin,” said the FDA’s Jean-Marc Guettier, M.D. “Today’s 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.”
Not a substitute for long-acting insulin, Afrezza needs to be combined with long-acting insulin in patients with type 1 diabetes. It is not recommended for treating diabetic ketoacidosis, or patients who smoke.
Peak insulin levels are seen within 12 to 15 minutes of administration, and return to baseline by around 180 minutes.
Type 1 Diabetes Evaluation Study
Safety and effectiveness of the drug were assessed in 3,017 participants. 1,026 of the participants had type 1 diabetes and 1,991 patients had type 2 diabetes.
The effectiveness of mealtime Afrezza in adult patients with type 1 diabetes patients was compared to mealtime fast-acting insulin aspart, in combination with basal long-acting insulin insulin in a 24 week study.
When week 24 was reached, treatment with basal insulin and mealtime Afrezza showed a mean reduction in hemoglobin A1c or glycosylated hemoglobin (HbA1c- a measure of blood sugar control), that met the specified non-inferiority margin of 0.4 percent.
Afrezza provided less HbA1c reduction than insulin aspart, and the difference was statistically significant.
Type 2 Diabetes Study
Afrezza was also studied in adults with type 2 diabetes in combination with oral antidiabetic drugs. Efficacy of mealtime Afrezza in type 2 diabetes patients was compared to placebo inhalation in a 24 week study.
When week 24 was reached, treatment with Afrezza plus oral antidiabetic drugs gave a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction seen in the placebo group.
Afrezza, which is manufactured by the MannKind Corporation, 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 due to this risk.
The most common adverse reactions linked to Afrezza in the clinical trials were cough, hypoglycemia, and throat pain or irritation.
“Approval of AFREZZA is an important milestone for MannKind, as today’s FDA action validates the years of clinical research and commitment that powered the development of this unique therapy,” said Alfred Mann, MannKind Corporation’s CEO. “We are excited for patients, as we believe that AFREZZA’s distinct profile and non-injectable administration will address many of their unmet needs for mealtime insulin therapy, and has the potential to change the way that diabetes is treated. We thank the more than 6,500 adult patients and healthy volunteers who participated in the AFREZZA clinical program.”
Image by Alden Chadwick, Creative Commons 2.0 License