Inhaled Insulin Delayed
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FDA Delays Decision on Inhaled Insulin
The FDA was expected to announce its decision on inhaled insulin this week. Inhaled insulin is a brand new technology that would allow diabetics to take insulin via inhalation. Insulin has historically always been administered via injection or sometimes by insulin pumps.
There are currently 18-20 million people in the United States that are diabetic. The majority of these patients are taking insulin via the traditional methods. The companies responsible for this new technology are Pfizer and Sanofi-Aventis. This new form of insulin drug is called Exubera. Exubera is an inhaled version of insulin.
The FDA advisory committee twice voted 7-2 to recommend that the agency approve the drug and inhaler device for sale in the United States
If approved, Exubera would be the first inhaled insulin product on the market. Exubera would be used to treat people with type 1 and type 2 diabetes mellitus.
Technical Data Review
According to a recent report, the FDA wants to review additional technical chemistry data. FDA advisers who originally voted to recommend inhaled insulin said its potential benefits outweighed certain problems. There is concern as to whether the effects of the drug on people with lung disease had been fully studied.
Other FDA advisers are concerned doctors and people with diabetes may not be properly trained in the use and maintenance of the inhaler device. Representatives from Pfizer and Sanofi-Aventis suggested that the inhaler was not any more complicated than the insulin injections many diabetics now use.
The State of Diabetes
The diabetes population in the United States continues to grow each year. Estimates have the incidence of diabetes affecting from 100-300 million people over the next decade. The increase in type 2 diabetes has a direct link to the incidence of obesity in the United States.
People, who feel they are at risk for type 2 diabetes, should maintain a low fat diet, and participate in daily exercise. Simple life-style changes like this can reduce the chances of becoming diabetic. It is important to consult your primary care doctor prior to starting any new exercise regimen.