Novel Inhaled Insulin Approved for Diabetes — Physician’s First Watch
Novel Inhaled Insulin Approved for Diabetes
By Kristin J. Kelley
The FDA on Friday approved a rapid-acting inhaled insulin powder (marketed as Afrezza) for treating types 1 and 2 diabetes. The drug — taken at mealtime — must be used in conjunction with long-acting insulin in those with type 1 diabetes.
In clinical trials, Afrezza was shown to be noninferior to standard mealtime injectable insulin for reducing hemoglobin A1c levels.
Patients with chronic lung disease (e.g., asthma, COPD) shouldn't use Afrezza due to an increased risk for bronchospasm; the drug's label carries a boxed warning to advise of this risk. It is also not recommended for smokers or for treating diabetic ketoacidosis. The most common side effects include cough, hypoglycemia, and throat pain.
The FDA previously rejected Afrezza twice, the New York Times reports, but an advisory panel finally voted to approve it this past April. Postmarketing studies will examine whether the inhaled insulin impairs lung function or increases the risk for lung cancer, and whether it's safe for children.