FDA Committee Recommends Approval of Inhaled Insulin Afrezza

Yesterday the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 1 to recommend approval of Afrezza, a form of insulin that is inhaled rather than injected. Developed by MannKind Corporation, Afrezza would be a new option for millions of diabetics.  Although there were more cases of lung cancer among those who received Afrezza in clinical trials than in control groups, the numbers were small.  Longer-term studies of the risk of long-term exposure of the lungs to insulin would be needed to more definitively assess the risk of lung cancer.  In the past, major pharmaceutical companies Pfizer, Novo Nordisk and Eli Lilly had abandoned efforts to offer inhaled insulin.  The founder of MannKind Corporation, aerospace and medical device entrepreneur Alfred E. Mann, believes that the Afrezza inhaler will be more successful because it is smaller and easier to use than Pfizer's abandoned product Exubera.  In clinical trials, Afrezza was less effective than injected insulin in reducing blood sugar for Type 1 diabetics, but performed marginally better for those with Type 2 diabetes.  MannKind suggested that inhaled insulin would appeal to patients who might otherwise avoid or delay injection insulin treatments.  The panel vote is not binding on the FDA, but the FDA usually follows the panel's recommendation.  
[1] Radick, L. "FDA Panel Says Yes to Inhaled Insulin Device," medpage TODAY (April 1, 2014).
[2] Pollack, A. "Inhaled Insulin Clears Hurdle Toward F.D.A. Approval," The New York Times (April 1, 2014).
[3] Edney, A. "MannKind Wins U.S. Panel Backing for Inhaled Insulin," Bloomberg (April 2, 2014).

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