FDA Response to Exubera - Inhaled Insulin - Expected this Weekend

By the end of the week the FDA will give Exubera the thumbs up or thumbs down for approval. Most analysts believe that the FDA will swing towards approval. See breaking news article today.

There are many exciting benefits that may come with patient use of Exubera. Perhaps the greatest is its method of administration. For millions of people having to not inject insulin via syringe or infusion set will be life-changing. Patient compliance will immediately increase. Like asthmatics, people with diabetes will be seen inhaling their pre-prandial or pre-meal “powder” shot. Parents with Type 1 children (or Type 2…these days) will feel a little less anger and helplessness that the littlest people with diabetes have a little less of a burden. Here is an actual sketch from Nektar, the company that developed the specialized inhaling system. (Go ahead, click on the icons next to the lungs to see how the system works.)

However, there are one or two other things you should know about Exubera: (For all you Infomaniacs…you will already know).

1. May only be used as a bolus. Exubera is a rapid-acting insulin (ideally starts quickly, finishes quickly). As said above, great news for all the T2’s who need a before meal shot to go along with their oral anti-diabetic meds. But the product doesn’t offer 24 hour coverage. Too bad.

2. Hypoglycemia is still at issue. Major studies have been done for years that have said lack of adherence to insulin regimens is directly related to fear of hypos. It can also be seen a different way. If you are a parent, what is your greatest fear if your child is on insulin therapy? All of you adult children of parents with insulin dependent diabetes, what is your greatest fear when “Grandpa” gets in his car to drive home after a family gathering?

And lastly, for all diabetes sufferers currently on insulin therapy, what do you hate most about the disease?Injections?
Not being able to eat candy?
Or waking up in the middle of the night in a pool of sweat, with impaired vision and an inability to communicate? (or on a mid-town subway car and one life-saver, or in an auditorium listening to your daughter’s first piano recital, or taking the SAT’s (USA) for the first time or your GCSE’s (UK) and so on.)

For me, hands down, insulin –whatever the administration - makes diabetes difficult. Full-stop.

Please remember, beef, pork, synthetic, even inhaled insulin is not a cure.