FDA Approves Rapid-Acting Inhaled Insulin Powder

The FDA has approved Afrezza, a rapid-acting inhaled insulin powder used to improve glycemic control in type 1 and type 2 diabetes.

Afrezza is administered within the 20 minutes of beginning a meal and should be used in combination with basal insulin in type 1 diabetics and glucose-lowering medications in type 2 diabetics.
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To test the drug’s efficacy and safety, researchers followed 3027 participants, 1026 with type 1 diabetes and 1991 with type 2 diabetes, comparing results with Afrezza against fast-acting mealtime insulin, both in combination with basal insulin.

Over 24 weeks of study, Afrezza was shown to provide an average reduction in HbA1c that was non-inferior to standard injectable mealtime insulin.

Afrezza is not a substitute for long-acting insulin, and must be used in combination with standard insulin in patients with type 1 diabetes. 

Afrezza should not be used in patients with chronic lung disease, and has a boxed warning of acute bronchospasm in patients with chronic obstructive pulmonary disease.  Common side effects include hypoglycemia, cough, throat pain, and irritation.

A Risk Evaluation and Mitigation Strategy has been created for the drug, in an effort to inform health care professionals about the risk of bronchospasm. 

After 2 previous rejections from the FDA, an advisory panel finally voted to approve Afrezza in April 2014.  Postmarket studies will test the risk of lung cancer and decreased lung function in patients using inhaled insulin. 

–Michael Potts

Reference

US Food and Drug Administration. FDA approves Afrezza to treat diabetes [press release]. June 27, 2014. https://www.consultant360.com/exclusives/cause-herpes-virus-reactivation-revealed. Accessed June 30, 2014