Posted on 01/27/2006 8:29:09 PM PST by neverdem
FRIDAY, Jan. 27 (HealthDay News) -- Exubera, the first inhaled insulin treatment for diabetes, won approval from U.S. regulatory officials on Friday.
The long-awaited action by the U.S. Food and Drug Administration means millions of people with both type 1 and type 2 diabetes may have the option of avoiding the needles and countless injections that have marked their lives so far.
"This is highly positive. It will be a major advance for individuals with diabetes, both children and adults," said Dr. Robert Rapaport, director of the division of pediatric endocrinology at Mount Sinai School of Medicine in New York City. "I think there will be some longstanding questions about its ultimate safety because it's the first inhaled medication that will be used like this. But, assuming the safety profile will be good, it will be a major advance."
Added Dr. Stuart Weiss, an assistant clinical professor of medicine at New York University School of Medicine: "There are still some questions as to lung function and diffusion capacity, and smokers can't use it. There are all sorts of things to be concerned about. It's going to take a few years to see whether or not it's as safe as all that."
Exubera is the first new insulin delivery option introduced since the discovery of insulin in the 1920s, the FDA said.
The announcement follows European regulators' approval of Exubera on Thursday. A U.S. Food and Drug Administration advisory panel recommended approval of the drug in the United States on Sept. 8.
Type 2 diabetes has become a global epidemic, affecting some 12 million people in the United States alone. The condition, which develops when the pancreas does not produce enough insulin or the body cannot use the hormone efficiently, is strongly associated with overweight and obesity. While some people can manage their type 2 diabetes through diet and exercise, others must rely on insulin injections.
Type 1 diabetes, in which the body's insulin-producing capabilities are limited or non-existent, is not linked to body weight.
Insulin is the hormone that converts blood sugar, called glucose, into energy for cells in the body.
If left uncontrolled, either type of diabetes can lead to a multitude of complications, including amputations, blindness, kidney disease, heart attack and strokes.
The first commercial insulin hit the market in the 1920s. Since then, the gold standard for treatment of type 1 diabetes and more advanced type 2 diabetes has been insulin, injected before meals.
In the intervening years, new types of insulin formulations and devices have made the process more efficient.
"Needles are way, way smaller, syringes are easier to use, pen devices are very discreet, all sorts of delivery devices are very impressive," Weiss said. But the premise has remained the same -- delivery by injection.
Exubera, on the other hand, is a dry powder formulation of insulin inhaled into the lungs through the mouth. Like injectable insulin, it is administered before meals using a small, hand-held device.
Studies on safety and effectiveness were done on more than 2,500 adults with type 1 and type 2 diabetes. The drug, manufactured by Pfizer Inc., was as effective as injectable insulin for control of blood sugar, the company stated. Pfizer apparently delayed Exubera's application for U.S. approval for three years to finish safety studies.
In those clinical studies, Exubera reached peak insulin concentration more quickly than some insulins, called regular insulin, administered by injection. Peak insulin levels were achieved at 49 minutes, on average, with Exubera, compared to 105 minutes, on average, with regular insulin, the FDA said.
Prescriptions for Exubera will be accompanied by a "Medication Guide" containing FDA-approved information written especially for patients, the agency said.
Like any insulin product, low blood sugar is a side effect of Exubera and diabetics should carefully monitor their blood sugar regularly. Other side effects associated with Exubera in clinical trials included cough, shortness of breath, sore throat, and dry mouth, the FDA said.
Exubera shouldn't be used by smoker or someone who quit smoking within the last six months. The drug is also not recommended in people with asthma, bronchitis, or emphysema. And baseline tests for lung function are recommended before beginning treatment, and should be repeated every six to 12 months, according to the FDA.
Inhaled insulin is unlikely to completely replace injectable insulin. But, for many people, it may greatly improve glucose control.
"It's very hard to predict what the impact will be," Weiss said. "A lot of people who need to be on insulin are not on insulin. For that type 2 diabetic who is afraid of needles or will not take a shot, this is an ideal product. The problem is it doesn't address the root cause of diabetes. It could become another treatment that will cause people to overeat and under-exercise."
Exubera is also unlikely to be the only inhaled insulin on the market for long. Eli Lilly and Co., Kos Pharmaceuticals Inc., MannKind Corp. and Novo Nordisk A/S all are developing their own versions.
This is fabulous news.
I had to do injections for a short while until I was able to use other medications.
Talk about Yech
Wonderful!
Pfizer Inc. on Friday said its inhaled insulin drug Exubera has not yet been approved by U.S. regulators and it regrets an incorrect statement it made to business television channel CNBC about the regulatory status of the drug.
The company said it expects that the FDA will issue a decision concerning Exubera shortly.
Not quite yet but hopefully soon!
Whoever wrote this is a clueless idiot. T1 is linked to body weight? Huh?
I can see this being useful for long-term diabetics who have scar tissue built up from decades of shots/pump therapy. Insulin is less effective in those conditions. But I am *seriously* concerned about damage to the lungs from this product.
"It could become another treatment that will cause people to overeat and under-exercise."
And another prejudice idiot spews his tripe without the slightest idea of what the heck he's actually talking about.
I have to say that I don't understand your post. The sentence you quoted stated that IDDM was not linked to body weight. Perhaps you wrote a typo?
Yup. Shouldn't post when tired. I missed the "not". (And I read the darn thing three times. Crap.)
I'm going a bit off topic here, but I don't think T2 is always linked to body weight. I know of one T2 (in particular) who was a skinny vegetarian before diagnosis.
I also wonder about the whole "T2 is linked to being fat" theory. About 6 years ago I suddenly gained 30 pounds (in less than a month) and started craving carbs like a fiend. I tried diet and exercise as soon as the scale started shooting up and ended up on a 800-900 cal a day diet with exercise. I gained another 10 pounds in just two weeks. (And, no. I didn't cheat. I wrote down *everything*.) I went to the dr and found out that I had insulin resistance, but was not yet a T2. I was put on Metformin and a low carb diet and, after a year, I was back to normal.
I'm thinking that the carb cravings and the weight gain are not a self-induced situation that results in T2 diabetes, but symptoms of the beginning of the disease.
I digress. Back to the article. My son is a T1 and we will NOT be using the inhaled insulin for a very long time. Shots are really not that big of a deal for this diabetic and I am seriously concerned about the side-effects for the lungs.
Either you're drinking Jolt or you don't have kids or you're a vampire.
Or you're hyped up from SciFi Friday...
Confess! Which one is it?
Now that all being said, if the genetic tendency to develop insulin resistance is especially strong for an individual, that person can develop NIDDM without being overweight. However, if that person were overweight, they would invariably develop the insulin resistance at a younger age.
At least, that's what my biochemistry professor told me when I was an MS1.
I've no kids. I've never had Jolt, but I do drink my fair share of coffee. I just do my best studying at night. :-)
This is the theory that I disagree with. I believe that the genes are expressed when exposed to environmental stimuli (IE: carbohydrates), even before the weight gain is apparent. Weight gain is a symptom of the gene expression, not a stimulus of the disease.
And you CANNOT have my blood, vampire!! (I'm fetching the Holy Water now. I'm series.)
BTTT
Don't worry, when that occurs, they will market a drug for that.
Probably injectable.
"Cure Cancer?, Are you kidding, they're still mad over the money they lost curing polio!"
- Chris Rock -
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