Mannkind’s Afrezza Approved by FDA to Treat Diabetes

The U.S. Food and Drug Administration has approved a new drug Afrezza, a rapid-acting inhaled insulin, to treat adults with diabetes.

Currently in the United States there are 25.8 million people who are diagnosed with diabetes.  Further, high blood sugar levels can elevate the risk of serious complication including heart diseases, blindness and nerve and kidney damage.

Afrezza offers relief to those with diabetes mellitus by boosting the glycemic control.

Manufactured by Mannkind Corporation, Afrezza is a rapid acting inhaled insulin that is to be taken at the beginning of each meal, or within 20 minutes after starting a meal. It is not a substitute to long-acting insulin and should be used in combination with long-acting insulin in patients with type 1 diabetes and is not meant for treating diabetic ketoacidosis, or those patients who smoke.

"Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin," said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research. "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."

The safety and effectiveness of the drug was evaluated in 3,017 patients in which 1,026 had type 1 diabetes and 1,991 patients had type 2 diabetes.  A few were given mealtime Afrezza in combination with basal insulin and others were given mealtime insulin, in combination with basal insulin.  Atter 24 weeks, those given Afrezza had a mean reduction in HbA1c (hemoglobin A1c or glycosylated hemoglobin).

This reduction met the pre-specified non-inferiority margin of 0.4 percent. Afrezza provided less HbA1c reduction than insulin aspart, and the difference was statistically significant. The same results were achieved when efficacy of mealtime Afrezza was tested in type 2 diabetes patients.

Afrezza can cause acute bronchospasm in patients with asthma and chronic obstructive pulmonary disease (COPD). FDA warns that the drug is not meant for those with chronic lung disease like asthma or COPS. Some of the common adverse reaction reported were hypoglycemia, cough and throat pain or irritation.