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Post by careful2invest on Mar 12, 2017 14:36:43 GMT -5
I just watched a commercial for Januvia,
It starts out, "If you are a type 2 Diabetic (I then said to my son, "I would be so happy if this was a commercial for AFREZZA")
But of course, two plus years after FDA Approval, still non existent.
But back to my point... Have you noticed the warnings of possible side effects of Januvia?
Kidney problems, (some needing Dialysis) severe pain in your abdomen, vomiting, possible rash, hives, swelling of the face, lips, tongue and throat. Hypoglycemia, a possible blood test prior to and while using Januvia to
check Kidney function, with the most common side effects being upper respiratory tract infections, stuffy or runny nose, sore throat and headache. And last but not least... Pancreatitus, which could lead to Death!
Yet AFREZZA has a black box warning that in two plus years, MNKD has been unable to get revised?
And take a look at the warnings for Toujeo, Metformin, etc etc.
We need a more agressive approach to rectifying the many issues that are hurting AFREZZA'S market acceptance!
And yes, of course, Advertising AFREZZA will not hurt the brand either...(I still do not get that)
But the FDA warnings for AFREZZA need to be re evaluated asap!
Why they have not made the necessary changes as yet just does not make sense!
Still hoping, Still praying, Still waiting for MNKD to show some chutzpah!
Have a nice Sunday!
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Post by seanismorris on Mar 12, 2017 15:06:07 GMT -5
Is the FDA going to change the Label without some sort of trial (data)?
They say they're talking to the FDA. Does that really mean anything?
There are no open trials... so with no new data to present, I'm doubtful a change is coming anytime soon.
May be after the Pediatric Trial.
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Post by peppy on Mar 12, 2017 15:15:59 GMT -5
Farxiga commercial on youtube meet the press video.
www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s000lbl.pdf
Dapagliflozin dose of 10 mg per day in patients with type 2 diabetes mellitus for 12 weeks resulted in excretion of approximately 70 grams of glucose in the urine per day at Week
12. A near maximum glucose excretion was observed at the dapagliflozin daily dose of 20 mg. Dapagliflozin 3-Oglucuronide accounted for 61% of a 50 mg [14C]-dapagliflozin dose and is the predominant drug-related component in human plasma.
Elimination
Dapagliflozin and related metabolites are primarily eliminated via the renal pathway. In subjects with mild and moderate hepatic impairment (Child-Pugh classes A and B), mean Cmax and AUC of dapagliflozin were up to 12% and 36% higher, •
Bladder Cancer: An imbalance in bladder cancers was observed in clinical trials. FARXIGA should not be used in patients with active bladder cancer and should be used with caution in patients with a prior history of bladder cancer. (5.6)
•
Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with FARXIGA or any other antidiabetic drug. (5.7)
The most common adverse reactions associated with FARXIGA (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, and urinary tract infections. (6.1)
if glucose was supposed to be excreted through the bladder,.....
so the physicians willing to take out peoples kidneys because?
Because the guidelines say so?
Oh, that's right, because they are conservative.
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Post by peppy on Mar 12, 2017 15:19:53 GMT -5
Is the FDA going to change the Label without some sort of trial (data)?
They say they're talking to the FDA. Does that really mean anything? There are no open trials... so with no new data to present, I'm doubtful a change is coming anytime soon. May be after the Pediatric Trial. quote: Is the FDA going to change the Label without some sort of trial (data)?
reply: www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf YES. This is required data after the approval, so yes.
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Post by dreamboatcruise on Mar 12, 2017 15:20:41 GMT -5
I just watched a commercial for Januvia, It starts out, "If you are a type 2 Diabetic (I then said to my son, "I would be so happy if this was a commercial for AFREZZA") But of course, two plus years after FDA Approval, still non existent. But back to my point... Have you noticed the warnings of possible side effects of Januvia? Kidney problems, (some needing Dialysis) severe pain in your abdomen, vomiting, possible rash, hives, swelling of the face, lips, tongue and throat. Hypoglycemia, a possible blood test prior to and while using Januvia to check Kidney function, with the most common side effects being upper respiratory tract infections, stuffy or runny nose, sore throat and headache. And last but not least... Pancreatitus, which could lead to Death!Yet AFREZZA has a black box warning that in two plus years, MNKD has been unable to get revised? And take a look at the warnings for Toujeo, Metformin, etc etc. We need a more agressive approach to rectifying the many issues that are hurting AFREZZA'S market acceptance! And yes, of course, Advertising AFREZZA will not hurt the brand either...(I still do not get that) But the FDA warnings for AFREZZA need to be re evaluated asap! Why they have not made the necessary changes as yet just does not make sense! Still hoping, Still praying, Still waiting for MNKD to show some chutzpah! Have a nice Sunday! Seems like you are arguing that the existing Afrezza label should be a positive for us since it doesn't seem nearly as bad as a lot of the anti-diabetes drugs. The fact that Januvia may in some cases cause "death" from pancreatitus doesn't have any impact on whether or not warning about COPD, etc. is appropriate on Afrezza's label. Here is the Black Box. Do you really think this black box is at the crux of lack of Afrezza sales? What do you think the FDA would be justified in changing? WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE • Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA. [see Warnings and Precautions (5.1)]. • AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD. [see Contraindications (4)]. • Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients [see Dosage and Administration (2.5), Warnings and Precautions (5.1)]. |
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Post by slugworth008 on Mar 12, 2017 15:28:57 GMT -5
I just watched a commercial for Januvia, It starts out, "If you are a type 2 Diabetic (I then said to my son, "I would be so happy if this was a commercial for AFREZZA") But of course, two plus years after FDA Approval, still non existent. But back to my point... Have you noticed the warnings of possible side effects of Januvia? Kidney problems, (some needing Dialysis) severe pain in your abdomen, vomiting, possible rash, hives, swelling of the face, lips, tongue and throat. Hypoglycemia, a possible blood test prior to and while using Januvia to check Kidney function, with the most common side effects being upper respiratory tract infections, stuffy or runny nose, sore throat and headache. And last but not least... Pancreatitus, which could lead to Death!Yet AFREZZA has a black box warning that in two plus years, MNKD has been unable to get revised? And take a look at the warnings for Toujeo, Metformin, etc etc. We need a more agressive approach to rectifying the many issues that are hurting AFREZZA'S market acceptance! And yes, of course, Advertising AFREZZA will not hurt the brand either...(I still do not get that) But the FDA warnings for AFREZZA need to be re evaluated asap! Why they have not made the necessary changes as yet just does not make sense! Still hoping, Still praying, Still waiting for MNKD to show some chutzpah! Have a nice Sunday! EXACTLY and EXACTLY - Grow a pair already MNKD management !!! |
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Post by careful2invest on Mar 12, 2017 15:38:52 GMT -5
Dreamboat wrote..."Do you really think this black box is at the crux of lack of Afrezza sales? What do you think the FDA would be justified in changing? "
Are you serious??
The issues are many, some have been overcome to a degree, (insurance coverage, etc..)
But This portion of the lable as well as the lack of the "Ultra fast acting" classification on the lable are just part of the problem.
You have been around long enough to know this is not "at the crux of lack of AFREZZA sales" A minimal amout of DD would answer that.
There are many issues as to why AFREZZA is not selling! Advertising is IMHO, the biggest obstacle at this point.
Not to mention the crookedness of BP!
And yes, my point was that Death is not a side effect of using AFREZZA, nor the other warnings, yet Januvia is advertising and selling,
And here we sit after a 5-1 reverse split at under $2.00.
It just does not make sense!
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Post by dreamboatcruise on Mar 12, 2017 16:00:53 GMT -5
Dreamboat wrote..."Do you really think this black box is at the crux of lack of Afrezza sales? What do you think the FDA would be justified in changing? " Are you serious?? The issues are many, some have been overcome to a degree, (insurance coverage, etc..) But This portion of the lable as well as the lack of the "Ultra fast acting" classification on the lable are just part of the problem. You have been around long enough to know this is not "at the crux of lack of AFREZZA sales" A minimal amout of DD would answer that. There are many issues as to why AFREZZA is not selling! Advertising is IMHO, the biggest obstacle at this point. Not to mention the crookedness of BP! And yes, my point was that Death is not a side effect of using AFREZZA, nor the other warnings, yet Januvia is advertising and selling, And here we sit after a 5-1 reverse split at under $2.00. It just does not make sense! Doctors and PBMs can see the pk/pd profile even without an "Ultra" on the label. That has not convinced them to get behind Afrezza. Might be nice to have that adjective, but I don't think that is going to be a game changer. At this point I think many of us are in agreement that advertising seems to be the one area that is actually under control of MNKD that needs to be addressed ASAP. I'm confident things would have been differently in the past year if there were more money available. Regarding doctors and PBM/insurance, we would really need to have superiority clinical trials. Lack of funds would seem to make sense as to why that has not been done yet. BP competitors are undoubtedly doing whatever they can to thwart Afrezza's success. |
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Post by mnholdem on Mar 12, 2017 16:25:47 GMT -5
You work with what you have.
"Afrezza inhaled insulin powder can help you control your blood sugar at mealtimes. Ask your doctor if Afrezza is right for you. Click. Snap. Inhale. Afrezza."
Later, if the FDA approves a new label, you can market it differently but, for now, MannKind needs to work with the label that was dealt to them.
Too many patients still haven't even heard that there is an inhaled mealtime insulin available to them.
Too many doctors still hear "inhaled insulin" and think of how Exubera failed.
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MannKind got the NDA back from Sanofi nine months ago. They have positioned themselves to succeed. They need to pull the trigger and market their revolutionary insulin. Start with "inhaled" and add "faster" later, once the FDA gives you the green light, but don't sit on your hands and wait for the perfect label.
You need to be marketing Afrezza now.
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Post by matt on Mar 12, 2017 16:39:38 GMT -5
Is the FDA going to change the Label without some sort of trial (data)? In a word, no. The only time FDA removes warnings is if there is substantial patient data (like 100,000 patient years with a post-market surveillance program) that shows the warning is not needed. In the case of Afrezza, most patients only stay on the drug for a very short time so the accumulated patients years of data is tiny compared with most other drugs. How many patients have been on Afrezza continuously as their only prandial insulin for more than one year? The refill rates would suggest not very many. The reality is that some patients will have reactions and the FDA is going to keep the warnings intact so long as that is true. Consider this actual drug warning: That is part of the warning for Bayer aspirin, a basic drug that has been sold since 1899. If that is the label for aspirin don't expect to get a risk free label for inhaled insulin. |
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Post by peppy on Mar 12, 2017 17:00:00 GMT -5
Is the FDA going to change the Label without some sort of trial (data)? In a word, no. The only time FDA removes warnings is if there is substantial patient data (like 100,000 patient years with a post-market surveillance program) that shows the warning is not needed. In the case of Afrezza, most patients only stay on the drug for a very short time so the accumulated patients years of data is tiny compared with most other drugs. How many patients have been on Afrezza continuously as their only prandial insulin for more than one year? The refill rates would suggest not very many. The reality is that some patients will have reactions and the FDA is going to keep the warnings intact so long as that is true. Consider this actual drug warning: That is part of the warning for Bayer aspirin, a basic drug that has been sold since 1899. If that is the label for aspirin don't expect to get a risk free label for inhaled insulin. Aspirin is over the counter. Matt is correct, the bronchospasm warning will not go away. Regarding the Label. The Class may change. The class now is fast acting, same as the subq analogs. two different things. afrezza.com/wp-content/uploads/2016/08/afrezza.pdf
Ever had a bronchospasm? It can be an uncontrollable cough, that lasts until the bronchial stops spasm.
Bronchospasm or a bronchial spasm is a sudden constriction of the muscles in the walls of the bronchioles. It is caused by the release (degranulation) of substances from mast cells or basophils under the influence of anaphylatoxins. It causes difficulty in breathing which can be very mild to severe
www.drugs.com/cg/bronchospasm.html What is bronchospasm?
Bronchospasm is a narrowing of your airway that usually comes and goes. It may make it hard for you to breathe.
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Post by mango on Mar 12, 2017 17:01:55 GMT -5
Is the FDA going to change the Label without some sort of trial (data)? In a word, no. The only time FDA removes warnings is if there is substantial patient data (like 100,000 patient years with a post-market surveillance program) that shows the warning is not needed. In the case of Afrezza, most patients only stay on the drug for a very short time so the accumulated patients years of data is tiny compared with most other drugs. How many patients have been on Afrezza continuously as their only prandial insulin for more than one year? The refill rates would suggest not very many. The reality is that some patients will have reactions and the FDA is going to keep the warnings intact so long as that is true. Consider this actual drug warning: That is part of the warning for Bayer aspirin, a basic drug that has been sold since 1899. If that is the label for aspirin don't expect to get a risk free label for inhaled insulin. For some reason I cannot find a single warning for any of the injectable insulins concerning these facts: 1) all injectable insulins are amyloidogenic 2) all injectable insulins contain amyloid precursors 3) all injectable insulins can cause localized insulin-derived amyloidosis The FDA invested a considerable amount of time and money helping Eli Lilly develop the first bacteria to be used to mimic the action of insulin via rDNA technology. The FDA also allowed their insulin to be approved via shoddy trials and basically fast-tracked it. They realized the monetary aspects of rDNA technology and capitalized on it. Do you really think the FDA would ever admit they helped develop an insulin that is amyloidogenic and failed to require long term studies on it? And they have since failed to require research, much less admit its existence and prevalence. All injectable insulins should be required to carry black box warnings with this information. Afrezza has been proven to not be amyloidogenic via pathology and histology confirmation. See how things work? I do. |
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Post by peppy on Mar 12, 2017 17:08:29 GMT -5
and first the polio vaccine mango, that is however recorded in history.
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Post by mango on Mar 12, 2017 17:24:34 GMT -5
and first the polio vaccine mango, that is however recorded in history. Yes, they did produce that as well, but I was moreso referring to Genetech's (but really Eli Lilly's because they colluded with the FDA in the production process, trials, and so forth regardless) as being the first licensed rDNA technology derived medicine. Injectable amyloidogenic insulin is the FDA's most prized success. They probably are pissed off and worried that there was someone smarter than them that created a non-amyloidogenic insulin. That you inhale. |
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Post by seanismorris on Mar 12, 2017 17:50:58 GMT -5
So... are we in agreement that without new data there won't be a Label change or it won't be a significant change?
MannKind could argue that the Label is to stringent. But it's not. The only thing that could change would be approved for Pediatric use. (Needs a Trial)
MannKind could argue that Afrezza is Ultra, but the FDA is unlikely to create a drug category for one poorly performing drug ($$$ wise). I look at a drug Label as similar to a legal precedence. It's not going to get changed easily...
The lung cancer risk, and reduced lung function is the major deterrent on the Label. The FDA has asked for a follow up study, that MannKind hasn't even started yet. So, nothing is going to change there.
The only other thing I can think of that could change is the recommended time for taking Afrezza. In other words, taking it immediately before eating rather than 15 minutes.
To be clear I very very much want Afrezza approved for Pediatric use!
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The biggest problem (for success) I see is getting Doctors to agree that patents need to figure out their own dosing. And, Doctors are just there to advise them (which is where the sales people come in)... I think Doctors HATE telling that to their patients.
To get a really tight, optimal range, with Afrezza it's on the patients.
I'm not saying the situation isn't going to approve, but it's most likely going to result from better coverage and creating patient awareness. Docs may get on board after seeing Afrezza really does work. But until then we're fight an entrenched status quo.
MARKETING, MARKETING, MARKETING
MannKind, just do it! (you procrastinating assholes)
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