“Today’s approval broadens the options available" for delivering insulin in people with diabetes, Jean-Marc Guettier, MD, director of the FDA's Division of Metabolism and Endocrinology Products, says in a news release.
The FDA estimates that 18.1 million people have diabetes. About 7 million more are undiagnosed, the agency says.
This is the third time the drug was up for FDA approval. Its maker, MannKind Corporation, conducted additional safety studies after the first two attempts.
Afrezza carries a warning as it may cause a sudden tightening of the chest. It is not recommended for people with asthma or COPD. It is also not recommended for people that smoke or for the treatment of diabetic ketoacidosis.
"Our expectation is it should be priced comparably to current fast-acting insulins delivered in pen form," says Matthew Pfeffer, a spokesman for MannKind.
Kathleen Doheny contributed to this report.