If lung damage turns out to be a complete non-issue, is there any reason why a diabetic will not want to use it over injected insulin. If there is nolong term sustainable lung damage associated with Afrezza, what advantage is there injecting oneself multiple times during the day when you can inhale a few puffs a day to get the same or even better results ?
Kevin - its really very simple, insurance coverage. If its not covered doctors may mention it but then say lets try something covered and lets see how you do. While there were many issues with exubera it biggest failure was it was not covered by insurance. Additionally, during 171 significantly less total hypoglycemia was observed in the AFREZZA-Gen2, about 50% and fasting blood glucose was significantly lower. If you want about a 50% less risk of hypoglycemia versus insulin aspart and insurance is paying for it, its really a no brainier. Once Rapp replaces his Lantus with degludec I think most of his issues will be solved especially if its delivered with Technospshere.
Sentiment: Strong Buy
171 proved you can't get the same results or better. You get worse results. You also suffer slight decrease in lung function until you discontinue use. You also have a cough. You still experience hypos, both mild and severe. If approval, there will be no completed long term lung studies done for at least 5 years. So for 5 years, you don't know what type of lung damage you could possibly be doing.
Exubera is the only inhalable insulin with long term studies and the company put a lung cancer on its label afterward. Only happened in 6 past smokers vs. 1 in the group that did not use the drug. But it was significant that Pfizer had to issue a press release on April 9, 2008 that it was changing the label.
Injectable insulin has zero lung cancer concerns. Zero cough concerns. Zero decreased lung function concerns, and offers better results.
Inhaling the insulin is also less discreet as you have to bring it up to your mouth for all to see when an insulin needle or pen can be discreetly injected into a leg under a table. Even if donein a bathroom stall, I can inject insulin with zero noise, whereas an inhalable insulin would make a noise.
Injectable insulin is much more convenient. An insulin pen is very simple to use and will last for weeks with no work, filling or replacing. The Dreamboat inhaler must be filled with the Afrezza cartridges each time it it used, discarded then filled again. Then the inhaler itself must be thrown out and replaced after a week or two.
Injectable insulin also allows for much smaller doses to be used. It offers more margin for error and tighter control. For example, if a T1 has a bg level at 130 and wants to bring it down just a bit to 85, he/she can take 1 unit of RAA and be done. The smallest cartridge of Afrezza (10 U cartridge) cannot do that and would bring down the bg level too low and cause a hypo (T1's will understand this much better than non-diabetics).
(to be continued).
Have you not been reading my posts, Kevin?
1. If you start on insulin, your life insurance rates go up. A lot. Or you might get dropped. There is a stigma against insulin use. Injected or not, Regular, slow, rapid doesn't matter. That stopped me for many years. Afrezza will face that same barrier that current insulin faces.
2. Afrezza is very mild. Almost every insulin can claim a (-1.6%) - (- 1.9%) effect on HbA1c when added to metformin or other oral agent in Type 2's. Afrezza will be able to claim either 0.4% against comparator or 0.82% single arm. These claims are regulated by the FDA, are part of the label / insert. Doctors & patients use them when choosing among options.
So - you asked the question - there's your answer. MANY people avoid a diagnosis of diabetes and live with uncontrolled diabetes for fear of economic consequences. Many Type 2's avoid being prescribed insulin therapy for the same reason.
I believe that Afrezza will be approved and come to market. I believe it will become a success, but that will be measured in a 2% - 3% market share. That's still really good - there are like 30 choices out there for treatment, and 2% - 3% represents $600M - 1 $B in sales. Phase 3 put an end to the possibility of Afrezza being the biggest drug ever, because although Affinity 2 shows Afrezza to have statistical clinical effect, it is not head-to-head competitive with injected.
Some people won't need a robust clinical effect, and in fact the milder effect if Afrezza might be right up their alley. For some like Afrezzauser it may be just the cat's pyjamas.
You refuse to see this evidence because it is not in your monetary interest to do so. I see it from the standpoint of a potential customer who will have to choose, and an investor who really wants the unrealistic expectation setting and attendant disappointment to just stop. Be realistic, be patient, and you will hopefully be rewarded.
rapp states: injectible insulin has......"Zero decreased lung function concerns, and offers better results."
who is this bozo? one day he's claiming to know everything. the next day he's flaunting it and then the dipstick comes to the same group to ask them questions for further clarity. i thought you were superior to all of us in your prognostications.
if you were that good, you wouldn't be asking questions here. such a fool.
i suggest you go back and review the data. there is no noticable effect on lung function. the company must disclose 'impact' but that doesn't mean it's noticable or a 'concern.' FDA has issues w/ lung impact greater than or equal to 1.30. afrezza vs control was 1.03.
you call that "concern?" if it were a concern why didn't go before an FDA advisory panel?
you must be dyslexic lol ok fella.
(cont. from prior post). In other words, glucose levels have to reach a certain level of hyperglycemia just to use it at all. If the bg level is too high (over 100, but under 135, for example) the patient would just have to live with it until their bg level increased to a high enough level to use the lowest possible dose of Afrezza. For many T1's who tightly control their diabetes and have A1c's less than 6%, this is a BIG disadvantage of Afrezza and will be a deal breaker for them.
Afrezza also requires complex titration (even though MNKD tried to sell it as a simple product that did not require complex titration, this is not true). 171 had very detailed and complex basal and bolus algorithms, yet still did worse in A1c's and still had many hypos. The 175 trial involved detailed training videos and coaching. Each trial required a 4 week run in period where the patients worked out the kinks and experimented with trial and error. Several patients dropped out of each trial for various reasons.
Anything new that is so complex will cause fear, concern and hesitation. Insulin therapy has a small window for error and is extremely difficult to manage regardless of delivery device. It is one of the reasons why Nova and Lilly (and Pfizer) abandoned all of their projects.
But the MOST important reason why Afrezza will not be used is simply because one must pay a 5-10% premium to use it. It has worse results, known and unknown side effects, less convenient, but costs much more. Injectable insulin has been around for 100 years. You know what you're getting. And it is cheap, cheap, cheap.