Inhaled Insulin Now Available in the United States

Sanofi and MannKind Corp. have announced the US launch of their Afrezza Inhalation Powder, the first and only insulin approved for administration via inhalation.

Afrezza was approved by the FDA in June 2014 to control high blood sugar in adults with type 1 and type 2 diabetes. The product consists of a dry formulation of human insulin delivered from a small and portable inhaler. Once administered, the insulin is rapidly absorbed and delivered to the bloodstream.

“Many people living with diabetes are not able to control their blood sugar on their current medications and may benefit from using insulin. Now, they have another option to administer insulin that is not an injection,” said Janet McGill, MD, professor of medicine at the Washington University School of Medicine in St. Louis and Afrezza clinical trial investigator, in a press release. “This delivery option may help change the dialogue between health care professionals and people living with diabetes about initiating or intensifying insulin therapy.”

The FDA’s nod was based on positive results from trials evaluating Afrezza’s safety and efficacy in 3017 patients with type 1 and type 2 diabetes. As part of the drug’s approval, the FDA is requiring a number of post-marketing studies to determine its effect on pediatric patients, assess the potential risk of pulmonary malignancy, and characterize dose-response and within-subject variability.

Afrezza is not a substitute for long-acting insulin, so it must be used in combination with long-acting insulin in patients with type 1 diabetes. The most common side effect of insulin is low blood sugar (hypoglycemia), which can be life-threatening. Other adverse events associated with the use of Afrezza include cough, throat pain or irritation, headache, diarrhea, tiredness, and nausea.