FDA Approves Inhaled Insulin Afrezza for Diabetes

Miriam E. Tucker


June 27, 2014

The US Food and Drug Administration (FDA) has approved the inhaled human insulin product Afrezza (MannKind) to improve glycemic control in adults with type 1 and type 2 diabetes.

Afrezza is a rapid-acting inhaled insulin to be administered prior to meals or within 20 minutes of starting a meal. It is not a substitute for long-acting insulin and must be used in combination with long-acting insulin in patients with type 1 diabetes. It is not recommended for the treatment of diabetic ketoacidosis or in patients who smoke or who have chronic lung disease.

"Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin," said Jean-Marc Guettier, MD, 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 approval follows an FDA advisory panel meeting held in April, which voted in favor of Afrezza 13 to 1 for type 1 diabetes and 14 to 0 for type 2 diabetes.

Efficacy and safety data came from studies involving a total of 3017 patients, including 1026 with type 1 and 1991 with type 2 diabetes. At 24 weeks, Afrezza reduced HbA1c levels by the prespecified end point of 0.4 percentage points in both groups. Hemoglobin A1c reduction was inferior to that of insulin aspart among type 1 patients but significantly superior to placebo among type 2 patients who were also taking oral glucose-lowering medications.

The most common adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough, and throat pain or irritation. Afrezza will have a boxed warning advising that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease.

The FDA also approved Afrezza with a risk evaluation and mitigation strategy, including a communication plan to inform healthcare professionals about the serious risk for acute bronchospasm associated with the medication.

The FDA is requiring 4 postmarketing studies for Afrezza:

  • A clinical trial to evaluate pharmacokinetics, safety and efficacy in pediatric patients.

  • A clinical trial evaluating the potential risk for pulmonary malignancy with Afrezza, along with assessment of cardiovascular risk and long-term effect on pulmonary function.

  • 2 pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, 1 characterizing dose-response, the other within-subject variability.


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