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FDA Response to Exubera - Inhaled Insulin - Expected this Weekend

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24 January 2006

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.

1 Comments:

Blogger Ellen said...

240 page document prepared by Exubera to the FDA http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169B1_01_01-Pfizer-Exubera.pdf . I have no doubt FDA will approve. Big pharma yields tremendous power in the US.

How small a drop in your airway test would be acceptable to you? Research Probes Efficacy, Safety of Inhaled Insulin -- Simmons 1 (1): 12 -- DOC News ...A "small but clinically insignificant drop" was observed in some of the airways tests, said Anthony Barnett, MD, the lead study investigator for Exubera

Entrez PubMed ....The efficiency of inhaled insulin is lower than that of subcutaneous injection because pulmonary delivery of insulin involves some loss of drug within the inhaler or mouth during inhalation. A concern of many clinicians is the possibility of long-term effects from the intraalveolar deposition of insulin within the lung, since insulin is known to have growth-promoting properties. The long-term safety of these products has not been established.

Entrez PubMed ...In clinical trials of patients with type 1 or 2 diabetes who were treated with Exubera((R)), the only significant clinical adverse effect was cough. This was generally characterized as mild to moderate in severity, decreased over time and was not associated with declines in lung function.

Entrez PubMed ...Completed phase 2 and 3 studies up to 4 years in duration indicate that the differences over time in pulmonary function changes between patients treated with Exubera((R)) and control patients are small, non-progressive, clinically insignificant and reverse after discontinuation of Exubera((R)) therapy

Entrez PubMed ...Among various difficulties of the pulmonary insulin delivery, the finding of an effective promoter, capable of increasing the bioavailability of insulin, is a crucial issue. The cost of such insulin administration might also be a problem. Finally, careful studies concerning the safety of this kind of administration, particularly potential long-term pulmonary toxicity, are mandatory.

Persons with diabetes want to AVOID severe hypoglycemia. This is from an abstract of a recent Skyler article. Entrez PubMed... Inhaled insulin was associated with a lower overall hypoglycemia rate but higher severe hypoglycemia rate. ... Increased insulin antibody serum binding without associated clinical manifestations occurred in the inhaled insulin group. Pulmonary function between the groups was comparable, except for a decline in carbon monoxide-diffusing capacity in the inhaled insulin group without any clinical correlates.


http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169B1_01_01-Pfizer-Exubera.pdf
http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169B1_02_00-FDA-TOCTable%20of%20Contents.htm


http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4169S1_00_Slide-Index.htm

3:54 AM  

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