FDA Advisory Committee Recommends Approval of Mannkind’s Inhaled Insulin, Afrezza

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The U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 1 to recommend that Afrezza (insulin human [rDNA origin]) Inhalation Powder be granted marketing approval by the FDA to improve glycemic control in adults with type 1 diabetes and voted 14 to 0 to recommend that Afrezza be granted marketing approval by the FDA to improve glycemic control in adults with type 2 diabetes.

Afrezza is a novel, ultra rapid-acting mealtime insulin therapy developed by MannKind Corporation to improve glycemic control in adult patients with type 1 or type 2 diabetes. It is a drug-device combination product, consisting of AFREZZA Inhalation Powder delivered using a small, discreet and easy-to-use inhaler. Administered at the start of a meal, AFREZZA Inhalation Powder dissolves immediately upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12 to 15 minutes of administration, compared to 45-90 minutes for injected rapid acting insulin analogs and 90-150 minutes for injected regular human insulin.If approved, AFREZZA would be the first ultra rapid-acting mealtime insulin therapy available in the United States.

However, the FDA is not bound by the Advisory Committee’s recommendation but will consider its guidance in reviewing the New Drug Application (NDA) that was submitted for Afrezza. The FDA should complete its review of AFREZZA by April 15, 2014.

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