Phase 3 Studies of Afrezza Ultra-fast Inhaled Insulin

On May 31 and June 17, MannKind announced that it had completed its new phase 3 clinical studies of Afrezza for people with type 1 and 2 diabetes. As a reminder, Afrezza is an ultra-rapid-acting mealtime insulin taken through an inhaler that was previously denied FDA approval in January 2011. This insulin dissolves very quickly after inhalation so that insulin levels peak within 12 to 14 minutes, a huge improvement over the typical 60-90 minutes with current rapid-acting insulin (Humalog, Novolog, and Apidra). Both studies assessed A1c levels over 12 weeks. MannKind expects to release data in mid-August – we cannot wait to see the results, as this represents the first major advance in mealtime insulin since Humalog came to market more than 15 years ago. Since Afrezza comes in the equivalent of 3-4 unit dose increments, we will be particularly interested to see how well it works in type 1 diabetes. It likely won’t be a great option for those who are highly insulin sensitive or who take very little mealtime insulin, though Afrezza certainly could make a lot of sense for meals that contain a lot of carbohydrates, people with very high blood sugars, and people who are more insulin resistant. If all goes as planned, MannKind intends to resubmit Afrezza to the FDA in late September or October, placing a potential approval in March or April 2014 at the earliest. We are particularly interested in learning more about using Afrezza with various versions of the artificial pancreas. (DiaTribe)

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