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Post by agedhippie on Jan 6, 2020 8:21:31 GMT -5
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Post by matt on Jan 6, 2020 9:00:10 GMT -5
The prior version also mentioned inhaled insulin although I think the exact wording in this version is somewhat different. The wording makes it clear that the ADA does not consider the clinical trial work done to date sufficient to make a definitive recommendation on use of inhaled insulin or fast-acting insulin aspart without further studies. I think that is generally consistent with last year's version.
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Post by winstonsmith on Jan 6, 2020 9:29:54 GMT -5
Inhaled Insulin Inhaled insulin is available for prandial use with a limited dosing range; studies in people with type 1 diabetes suggest rapid pharmacokinetics (7). A pilot study found evidence that compared with injectable rapid-acting insulin, supplemental doses of inhaled insulin taken based on postprandial glucose levels may improve blood glucose management without additional hypoglycemia or weight gain (83), although results from a larger study are needed for confirmation. Inhaled insulin is contraindicated in patients with chronic lung disease, such as asthma and chronic obstructive pulmonary disease, and is not recommended in patients who smoke or who recently stopped smoking. All patients require spirometry (FEV1) testing to identify potential lung disease prior to and after starting inhaled insulin therapy. care.diabetesjournals.org/content/43/Supplement_1/S98 |
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Post by mango on Jan 6, 2020 9:38:49 GMT -5
Couple more comments on Afrezza I found:
Injecting insulin with a syringe or pen is the insulin delivery method used by most people with diabetes (76,77), although inhaled insulin is also available.
Inhaled human insulin has a rapid peak and shortened duration of action compared with RAA and may cause less hypogly- cemia and weight gain (7), and faster- acting insulin aspart may reduce prandial excursions better than RAA (8);
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Post by akemp3000 on Jan 6, 2020 10:35:00 GMT -5
"Compared with injectable rapid-acting insulin, supplemental doses of inhaled insulin taken based on postprandial glucose levels may improve blood glucose management without additional hypoglycemia or weight gain"
Is there any reason this sentence with the reduced hypoglycemia and weight gain cannot now be marketed and emphasized to the public...even if it's necessary to be followed with a caveat stating "a larger study is needed"? I can only imagine how many diabetics would like to hear this.
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Post by peppy on Jan 6, 2020 10:41:26 GMT -5
"Compared with injectable rapid-acting insulin, supplemental doses of inhaled insulin taken based on postprandial glucose levels may improve blood glucose management without additional hypoglycemia or weight gain" Is there any reason this sentence with the reduced hypoglycemia and weight gain cannot now be marketed and emphasized to the public...even if it's necessary to be followed with a caveat stating "a larger study is needed"? I can only imagine how many diabetics would like to hear this. that is the ticket. add to pre-authorian letters. |
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Post by agedhippie on Jan 6, 2020 13:26:12 GMT -5
"Compared with injectable rapid-acting insulin, supplemental doses of inhaled insulin taken based on postprandial glucose levels may improve blood glucose management without additional hypoglycemia or weight gain" Is there any reason this sentence with the reduced hypoglycemia and weight gain cannot now be marketed and emphasized to the public...even if it's necessary to be followed with a caveat stating "a larger study is needed"? I can only imagine how many diabetics would like to hear this. The problem for Mannkind is that marketing must reflect the label and this is not on the label. Interestingly in the January edition of Diabetes Care there is a paper that essentially says that if you use a CGM your HbA1c is no longer correlated to severe hypos. In other words if you have a CGM you can be more aggressive in reducing your HbA1c because you do not increase your chances of a severe hypo. |
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Post by ilovekauai on Jan 6, 2020 15:21:49 GMT -5
Peppy, I agree. Do it, and do it now.
And, Happy New Year all!
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Post by sayhey24 on Jan 6, 2020 20:01:10 GMT -5
"Compared with injectable rapid-acting insulin, supplemental doses of inhaled insulin taken based on postprandial glucose levels may improve blood glucose management without additional hypoglycemia or weight gain" Is there any reason this sentence with the reduced hypoglycemia and weight gain cannot now be marketed and emphasized to the public...even if it's necessary to be followed with a caveat stating "a larger study is needed"? I can only imagine how many diabetics would like to hear this. The problem for Mannkind is that marketing must reflect the label and this is not on the label. Interestingly in the January edition of Diabetes Care there is a paper that essentially says that if you use a CGM your HbA1c is no longer correlated to severe hypos. In other words if you have a CGM you can be more aggressive in reducing your HbA1c because you do not increase your chances of a severe hypo. Aged - since the 2016, Amarin Pharmaceuticals settlement with the FDA little is stopping the MNKD reps from off-label promotion which would include promoting reduced hypos based on both the STAT and Affinity 1 studies. The settlement binds the FDA to the specific conclusion in Judge Engelmayer's decision affirming Amarin’s ability to disseminate off-label communications, including journal reprints, to health care professionals, as long as the communications are “truthful and non-misleading.” If we don't see all the new MNKD reps Mike is hiring leading with reduced hypos to the Endo's for T1 use, I would be shocked. Especially since it now has a mention in the SoC. |
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Post by mango on Jan 6, 2020 20:31:39 GMT -5
The problem for Mannkind is that marketing must reflect the label and this is not on the label. Interestingly in the January edition of Diabetes Care there is a paper that essentially says that if you use a CGM your HbA1c is no longer correlated to severe hypos. In other words if you have a CGM you can be more aggressive in reducing your HbA1c because you do not increase your chances of a severe hypo. Aged - since the 2016, Amarin Pharmaceuticals settlement with the FDA little is stopping the MNKD reps from off-label promotion which would include promoting reduced hypos based on both the STAT and Affinity 1 studies. The settlement binds the FDA to the specific conclusion in Judge Engelmayer's decision affirming Amarin’s ability to disseminate off-label communications, including journal reprints, to health care professionals, as long as the communications are “truthful and non-misleading.” If we don't see all the new MNKD reps Mike is hiring leading with reduced hypos to the Endo's for T1 use, I would be shocked. Especially since it now has a mention in the SoC. This proposed settlement is the first time the FDA has conceded that pharmaceutical companies may engage in truthful and non-misleading speech promoting the off label use of the prescription drugs. www.policymed.com/2016/03/amarin-and-fda-off-label-free-speech-settlement.html• While this ruling in Amarin, coupled with the Second Circuit’s decision in Caronia, appears to foreclose FDA from prosecuting a pharmaceutical manufacturer for truthful and non-misleading off-label promotion, it is important to note that this precedent has only been established in the Second Circuit to date and there is considerable uncertainty as to how sister Circuits would rule if faced with the same set of facts. • Finally, the limitation of First Amendment protection to truthful and non-misleading speech is not to be missed. Indeed, the court gave very practical advice to manufacturers when it said: Although the FDA cannot require a manufacturer to choreograph its truthful promotional speech to conform to the agency’s specifications, there is practical wisdom to much of the FDA’s guidance, including that a manufacturer vet and script in advance its statements about a drug’s off-label use. A manufacturer that leaves its sales force at liberty to converse unscripted with doctors about off-label use of an approved drug invites a misbranding action if false or misleading (e.g., one-sided or incomplete) representations result. Caronia leaves the FDA free to act against such lapses. [(Amarin at 53.)]www.fdalawblog.net/2015/08/a-victory-for-amarin-further-erodes-fda-regulation-of-off-label-promotion/————————————————— Taking the language used in the SoC, the clinical trials data backing it up, and Amarin/FDA conclusions—I’d have to agree with SayHey here, the reps should most definitely be regurgitating what the SoC has to say—especially considering it is the “Standard,” End All Be All, etc... |
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Post by sellhighdrinklow on Jan 6, 2020 21:27:36 GMT -5
Aged - since the 2016, Amarin Pharmaceuticals settlement with the FDA little is stopping the MNKD reps from off-label promotion which would include promoting reduced hypos based on both the STAT and Affinity 1 studies. The settlement binds the FDA to the specific conclusion in Judge Engelmayer's decision affirming Amarin’s ability to disseminate off-label communications, including journal reprints, to health care professionals, as long as the communications are “truthful and non-misleading.” If we don't see all the new MNKD reps Mike is hiring leading with reduced hypos to the Endo's for T1 use, I would be shocked. Especially since it now has a mention in the SoC. This proposed settlement is the first time the FDA has conceded that pharmaceutical companies may engage in truthful and non-misleading speech promoting the off label use of the prescription drugs. www.policymed.com/2016/03/amarin-and-fda-off-label-free-speech-settlement.html• While this ruling in Amarin, coupled with the Second Circuit’s decision in Caronia, appears to foreclose FDA from prosecuting a pharmaceutical manufacturer for truthful and non-misleading off-label promotion, it is important to note that this precedent has only been established in the Second Circuit to date and there is considerable uncertainty as to how sister Circuits would rule if faced with the same set of facts. • Finally, the limitation of First Amendment protection to truthful and non-misleading speech is not to be missed. Indeed, the court gave very practical advice to manufacturers when it said: Although the FDA cannot require a manufacturer to choreograph its truthful promotional speech to conform to the agency’s specifications, there is practical wisdom to much of the FDA’s guidance, including that a manufacturer vet and script in advance its statements about a drug’s off-label use. A manufacturer that leaves its sales force at liberty to converse unscripted with doctors about off-label use of an approved drug invites a misbranding action if false or misleading (e.g., one-sided or incomplete) representations result. Caronia leaves the FDA free to act against such lapses. [(Amarin at 53.)]www.fdalawblog.net/2015/08/a-victory-for-amarin-further-erodes-fda-regulation-of-off-label-promotion/————————————————— Taking the language used in the SoC, the clinical trials data backing it up, and Amarin/FDA conclusions—I’d have to agree with SayHey here, the reps should most definitely be regurgitating what the SoC has to say—especially considering it is the “Standard,” End All Be All, etc... Here's hoping M C is reading this and takes heed. |
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Post by goyocafe on Jan 6, 2020 22:10:57 GMT -5
This proposed settlement is the first time the FDA has conceded that pharmaceutical companies may engage in truthful and non-misleading speech promoting the off label use of the prescription drugs. www.policymed.com/2016/03/amarin-and-fda-off-label-free-speech-settlement.html• While this ruling in Amarin, coupled with the Second Circuit’s decision in Caronia, appears to foreclose FDA from prosecuting a pharmaceutical manufacturer for truthful and non-misleading off-label promotion, it is important to note that this precedent has only been established in the Second Circuit to date and there is considerable uncertainty as to how sister Circuits would rule if faced with the same set of facts. • Finally, the limitation of First Amendment protection to truthful and non-misleading speech is not to be missed. Indeed, the court gave very practical advice to manufacturers when it said: Although the FDA cannot require a manufacturer to choreograph its truthful promotional speech to conform to the agency’s specifications, there is practical wisdom to much of the FDA’s guidance, including that a manufacturer vet and script in advance its statements about a drug’s off-label use. A manufacturer that leaves its sales force at liberty to converse unscripted with doctors about off-label use of an approved drug invites a misbranding action if false or misleading (e.g., one-sided or incomplete) representations result. Caronia leaves the FDA free to act against such lapses. [(Amarin at 53.)]www.fdalawblog.net/2015/08/a-victory-for-amarin-further-erodes-fda-regulation-of-off-label-promotion/————————————————— Taking the language used in the SoC, the clinical trials data backing it up, and Amarin/FDA conclusions—I’d have to agree with SayHey here, the reps should most definitely be regurgitating what the SoC has to say—especially considering it is the “Standard,” End All Be All, etc... Here's hoping M C is reading this and takes heed. Huevos? Cajones? Bullocks? Cobblers? MC, take your pick, but pick a pair!!! |
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Post by agedhippie on Jan 6, 2020 22:12:49 GMT -5
The problem for Mannkind is that marketing must reflect the label and this is not on the label. Interestingly in the January edition of Diabetes Care there is a paper that essentially says that if you use a CGM your HbA1c is no longer correlated to severe hypos. In other words if you have a CGM you can be more aggressive in reducing your HbA1c because you do not increase your chances of a severe hypo. Aged - since the 2016, Amarin Pharmaceuticals settlement with the FDA little is stopping the MNKD reps from off-label promotion which would include promoting reduced hypos based on both the STAT and Affinity 1 studies. The settlement binds the FDA to the specific conclusion in Judge Engelmayer's decision affirming Amarin’s ability to disseminate off-label communications, including journal reprints, to health care professionals, as long as the communications are “truthful and non-misleading.” If we don't see all the new MNKD reps Mike is hiring leading with reduced hypos to the Endo's for T1 use, I would be shocked. Especially since it now has a mention in the SoC. That would certainly be a good lead given that it seems it can be done. The counter-argument will be that there are a lot of ways to reduce hypos; use of CGMs is one, augmented pumps like the Tandem Control IQ or the Medtronics 670G is another. Since we are talking about the Type 1 market now given Mike's targeting comments both of those are probably already in use, or an easy insurance sell in the case of the 670G (they have a deal with insurers where Medtronics rebates any ER costs for their pump users). What the endos will be looking for is the biggest impact for the smallest disruption to current practice. That said; lower hypo rate will always get attention but they are going to want to drill down into the data. |
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Post by akemp3000 on Jan 6, 2020 22:25:43 GMT -5
Once diabetics learn the options to reduce hypos are a CGM, an augmented pump or a puff of Afrezza, and understand the differences in practical use, they will help with this decision which was the original point for bringing this up. Cmon Mike!
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Post by sayhey24 on Jan 7, 2020 6:35:52 GMT -5
Aged - since the 2016, Amarin Pharmaceuticals settlement with the FDA little is stopping the MNKD reps from off-label promotion which would include promoting reduced hypos based on both the STAT and Affinity 1 studies. The settlement binds the FDA to the specific conclusion in Judge Engelmayer's decision affirming Amarin’s ability to disseminate off-label communications, including journal reprints, to health care professionals, as long as the communications are “truthful and non-misleading.” If we don't see all the new MNKD reps Mike is hiring leading with reduced hypos to the Endo's for T1 use, I would be shocked. Especially since it now has a mention in the SoC. That would certainly be a good lead given that it seems it can be done. The counter-argument will be that there are a lot of ways to reduce hypos; use of CGMs is one, augmented pumps like the Tandem Control IQ or the Medtronics 670G is another. Since we are talking about the Type 1 market now given Mike's targeting comments both of those are probably already in use, or an easy insurance sell in the case of the 670G (they have a deal with insurers where Medtronics rebates any ER costs for their pump users). What the endos will be looking for is the biggest impact for the smallest disruption to current practice. That said; lower hypo rate will always get attention but they are going to want to drill down into the data. Aged - Counter-argument, really??? Adding CGMs to afrezza use is not a counter-argument. The use of CGMs with afrezza is synergistic. They work hand in hand. For T1s CGMs and afrezza should be the hands-down standard prior to any RAA use. One thing we do know by looking at the CGM post meal is afrezza can stop the spike and RAA's not so much. We also know by looking at the CGM is if you are runnning high nothing brings down BG for the T1 faster than afrezza. I would be hoping MNKD is developing very strong relationships with the three leading CGM providers. In fact Kevin Sayer was on Al Mann's team when afrezza was invented and my favorite Kevin Sayer quote is when he was asked about afrezza to which he responded he has "never seen anything like it". |
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