A Diabetes Game Changer? FDA Approves Inhalable Insulin

07 July 2014

Diabetes treatment in the United States could be due for some radical change now that the FDA has approved MannKind Corp.’s Afrezza fast-acting, inhalable insulin.

Valencia, CA–based MannKind announced the approval late last week. Type 1 diabetics would still need shot of long-acting insulin, but could supplement them with use of an Afrezza inhaler, while type 2 could potentially get insulin without injections.

The big open question is how much the Afrezza approval will affect the diabetes care market when it comes to Medtronic, Johnson & Johnson and other companies’ work on "smart" insulin pumps outside the body that could act as an artificial pancreas, adjusting insulin levels automatically based on glucose sensor readings and computer algorithms that anticipate the user's behaviour.

Could the smartest, and cheapest, insulin therapy of all simply be to use an insulin inhaler before a big meal?

The FDA approval comes a few months after Mannkind's drug-and-inhaler combination device received the go-ahead from FDA's Endocrinologic and Metabolic Drugs Advisory Committee. The committee’s vote at the time was a bit of a surprise because of concerns that long-term exposure to inhalable insulin might potentially cause lung cancer,according to The New York Times.

Even now, the treatment is not recommended for smokers. And the FDA is requiring a Risk Evaluation and Mitigation Strategy to ensure that the benefits of Afrezza outweigh the potential risk of acute bronchospasm in patients with chronic lung disease.

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