The rapid-acting medicine can be used at the beginning of a meal or within 20 minutes after the start of a meal to control glycemic levels in adults with diabetes.
"Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin," said Dr. Jean-Marc Guettier, 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 drug was tested in 3,017 patients, 1,026 with type 1 diabetes and 1,991 with type 2. The FDA said Afrezza was not a substitute for long-acting insulin and must be used in combination with long-acting insulin for patients with type 1 diabetes.
It also can't be used to treat diabetec ketoacidosis or by patients who smoke. The drug is manufactured by MannKind Corporation out of Danbury, Conn.
Some 25.8 million people in the United States have diabetes, which is about 8.3 percent of the total population.