Posted on 10/28/2005 9:45:16 AM PDT by BenLurkin
WASHINGTON - The Food and Drug Administration is delaying a final decision on the first inhalable form of insulin for three months while it reviews chemistry data on the diabetes treatment.
The agency's decision on whether the drug could be marketed to the public had been expected this week. The drug companies that developed the treatment said Friday the FDA notified them of the extended review.
Last month, an FDA advisory committee twice voted 7-2 to recommend that the agency approve the drug and inhaler device for sale in the United States. The separate votes were for each of the two major types of diabetes. The FDA usually follows the recommendations of its advisory committees, but is not required to.
Developers Pfizer, Sanofi-Aventis and Nektar Therapeutics promoted the drug as a convenient alternative to the injections millions of diabetics must take several times daily. It would be marketed under the name "Exubera."
The companies said the FDA wanted to review "additional technical chemistry data" they submitted. They did not provide details.
Advisers who voted to recommend inhaled insulin said its potential benefits outweighed certain problems, most notably whether the effects of the drug on people with lung disease had been fully studied.
Other advisers worried doctors and people with diabetes may not be properly trained in the use and maintenance of the inhaler device. Drug company representatives suggested that the inhaler was not any more complicated than the injections many diabetics now use.
Also this week, developers of another drug to help diabetics control blood sugar levels as well as cholesterol said they are unsure whether they will continue to pursue the treatment after the FDA sought additional safety data about it.
Bristol-Myers Squibb, which developed the pill along with Merck, said the studies required to obtain that data could take up to five years to perform. The drug, muraglitazar, would be marketed under the name Pargluva.
The FDA and some doctors who examined company data from drug trials raised concerns that the treatment could be associated with heart problems.
Bristol-Myers Squibb, based in Princeton, N.J., released a statement Thursday saying it "will continue discussions with the FDA and will consider a range of options including conducting additional studies or terminating further development of muraglitazar."
Last week, the companies said the FDA had issued them an letter saying the drug was approvable if the companies met certain conditions, but the agency's request for more heart safety data had not been made public until Bristol-Myers Squibb issued its statement Friday.
The drug had appeared headed for the market after members of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 8-1 to recommend FDA approval of the drug to treat Type II diabetes, the most common form of the condition, when used alone. The FDA usually follows the advice of its committees but is not required to do so.
The Journal of the American Medical Association last week published an analysis by heart researchers that found twice as many deaths and cardiovascular problems in diabetic adults taking the drug Pargluva as those on dummy pills or a competing drug.
About 18 million people in the United States are thought to have diabetes, although many do not know it. Untreated diabetes can lead to blindness, loss of limb function, even death.
Most have Type 2, a condition linked to obesity that occurs when the body cannot effectively use the insulin it makes. Sometimes this can be treated with pills instead of injections.
Fewer than 10 percent have Type 1, a disorder in which the immune system attacks insulin-producing cells in the pancreas. This is sometimes called juvenile diabetes.
abolish the FDA!
Back to the needles, boys.
Good morning.
*blood glucose check* Ow.
*injection* Ow.
Lunch break. Ooo...that looks good. Probably means I can't eat it. Oh well.
*blood glucose check* Ow.
*injection* Ow.
*blood glucose check* Ow.
*injection* Ow.
*blood glucose check* Ow.
*injection* Ow.
Good night.
Welcome to my hell.
Sucks, doesn't it?
I've been diabetic again for about a month now. There's a damn donut in the kitchen that has been calling to me since last night.
The suck factor is indeed high. Especially on the holidays.
Fortunately, there's Splenda. Otherwise I'd be whipping out my chainsaw and firing it up.
I've been diabetic again for about a month now.
Sorry, man. Well, you've got company. I went diabetic last year after losing 2/3rds of my pancreas (malignant pancreatic cancer). What brought yours on?
So glad you're still with us. PC is a scary deal.
I guess I'm prone to it, but about four years ago I went through two back to back courses of high-dose prednisone; one for bronchitis and the other for Bell's palsy. About two weeks after the second course, I ended up in the hospital with ketoacidosis. I was on injectible insulin for about six months and then my blood sugar went back to normal. I've had normal BGs until about a month ago. Out of the blue my BG shot up to over 400. So, I'm back to sticking myself.
Oh yeah, Splenda is great. So far all I'm using it for is to sweeten beverages. Have you tried it in anything baked? I wonder if it's any good that way. I can't stand the taste of aspartame, not to mention the tingling in my hands and feet when I've had it.
Yes, indeed. Last year we made a pumpkin pie and other treats for Thanksgiving with Splenda. It was just like the genuine article and very tasty. We got the bags of what I call "rice krispy" Splenda; it's the same stuff, but the volume of the granules is puffed up so you can do a 1:1 replacement for any recipe that requires sugar. That's pretty cool in my book.
I can't stand the taste of aspartame, not to mention the tingling in my hands and feet when I've had it.
Aspartame never used to bother me until I quit smoking (after I went through surgery of course). Then I couldn't abide by the taste...and it did REALLY weird things to my metabolic balance. Guh. I care not to think of the misery of having to eat stuff with that crap any longer.
Thanks much! Yeah...it is a tough one. The type I was diagnosed with is a rare one. It doesn't respond to chemo or radiation and has a 96% mortality rate in the first 18 months following treatment. I am presently at the 16th month after treatment.
I've had normal BGs until about a month ago. Out of the blue my BG shot up to over 400. So, I'm back to sticking myself.
Yikes. Sounds like you've really been through the wringer! I can relate to the absurdly high BG. Mine spiked out at over 600 at one point. I don't remember any of it. I learned later I was in some kind of delirium and wasn't making any sense at all. I'm amazed anyone was able to tell the difference. ;o)
"I am presently at the 16th month after treatment."
Thank God for that. Sounds like you got to it in time. We'll keep you in our prayers.
The first time it happened, I went to the hospital alone. My wife had the flu at the time so I told her she needed to stay home and that it was probably nothing serious. My BG was 560-something and the docs were worried because my eyes were dilating. I wondered why everything seemed brighter on the drive over. ;-) Once there in the ER, a couple of times thought I was going to pass out. I was sicker than I realized and glad I made the drive over.
I'm type 2. You might want to check out the specs on Splenda, if you haven't, regarding chlorine. I tend to look more for the pink packet, myself.
No reason to truck with alarmists. Knowledge, however, is still power.
Have a great weekend.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.