The U.S. Food and Drug Administration (FDA) has approved an inhaled insulin powder (Afrezza, MannKind Corp.) designed to improve glycemic control in adults with diabetes mellitus. The drug is administered before meals.
The 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,” Jean-Marc Guettier, MD, director of the division of metabolism and endocrinology products in the FDA’s Center for Drug Evaluation and Research, said in a press release.
The new inhaled insulin powder must be used in combination with long-acting insulin in patients with type 1 diabetes, and it is not recommended for the treatment of diabetic ketoacidosis or in those who smoke. Also, it should not be used in those who have chronic lung disease such as asthma or chronic obstructive pulmonary disease because it may cause acute bronchospasm. The most common adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough, and throat pain or irritation.
The FDA has asked the manufacturer to conduct studies of the drug’s use in children as well as to assess pulmonary malignancy, pulmonary function and cardiovascular risks related to the drug.