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Post by goyocafe on May 17, 2018 17:49:51 GMT -5
sayhey24 ... to your #10, it seems bioexec is saying Kindall believes a label change to ultra-rapid can be achieved without additional trials. i wonder if that was already submitted to the fda. Stat and hypo data could likely support that. IIRC MC indicated during the last label push that an additional class of insulin would likely be driven by outside organizations such as the ADA and that the FDA wasn’t the agency to do this. I could be very wrong with my recollection. I guess that doesn’t stop the ADA providing a well timed nod regarding the issue should the FDA request such input.
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Post by sayhey24 on May 17, 2018 17:56:24 GMT -5
Thats a great follow-up question - Has an sNDA already been submitted? It would not surprise me if thats a planned PR for ADA week - label change has been submitted.
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Post by dreamboatcruise on May 17, 2018 18:07:32 GMT -5
i wonder if that was already submitted to the fda. Stat and hypo data could likely support that. IIRC MC indicated during the last label push that an additional class of insulin would likely be driven by outside organizations such as the ADA and that the FDA wasn’t the agency to do this. I could be very wrong with my recollection. I guess that doesn’t stop the ADA providing a well timed nod regarding the issue should the FDA request such input. I would guess that FDA would want some sort of input from ADA or other professional bodies on what should be the definition/threshold(s) of a new ultra-rapid designation. That's not something that is clear cut. Though certainly clear cut that if there ever is such a designation, Afrezza should get it as leading in all of the relevant metrics of onset, peak and clearance.
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Post by sayhey24 on May 17, 2018 18:08:17 GMT -5
i wonder if that was already submitted to the fda. Stat and hypo data could likely support that. IIRC MC indicated during the last label push that an additional class of insulin would likely be driven by outside organizations such as the ADA and that the FDA wasn’t the agency to do this. I could be very wrong with my recollection. I guess that doesn’t stop the ADA providing a well timed nod regarding the issue should the FDA request such input. I would be surprised if they got "utltra rapid" and I think you are right the ADA would have to define the class. I actually never liked that phrase because it continues to compare afrezza to the analogs. What I would rather see is "Near-Natural" because its human insulin and near mimics natural pancreatic release. FIASP could never claim that. Make a category like "ultra" and FIASP could also be included.
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Post by drman7 on May 17, 2018 18:25:03 GMT -5
IIRC MC indicated during the last label push that an additional class of insulin would likely be driven by outside organizations such as the ADA and that the FDA wasn’t the agency to do this. I could be very wrong with my recollection. I guess that doesn’t stop the ADA providing a well timed nod regarding the issue should the FDA request such input. I would be surprised if they got "utltra rapid" and I think you are right the ADA would have to define the class. I actually never liked that phrase because it continues to compare afrezza to the analogs. What I would rather see is "Near-Natural" because its human insulin and near mimics natural pancreatic release. FIASP could never claim that. Make a category like "ultra" and FIASP could also be included. I believe Mannkind should work on a label change that puts them on a category of inhaled or oral insulin (non injection insulin). Something that identifies the transport of insulin. If they can achieve that Afrezza will be the only one on that category and Novo and Lilly would be left with their pants down. Afrezza would be the leader in oral/inhale insulin. I doubt the ultra-fast or ultra-rapid will ever happen but the studies should identify that due to the way the insulin is taken with afrezza, hyperglycemia is not longer a critical issue.
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Post by dreamboatcruise on May 17, 2018 18:31:17 GMT -5
I would be surprised if they got "utltra rapid" and I think you are right the ADA would have to define the class. I actually never liked that phrase because it continues to compare afrezza to the analogs. What I would rather see is "Near-Natural" because its human insulin and near mimics natural pancreatic release. FIASP could never claim that. Make a category like "ultra" and FIASP could also be included. I believe Mannkind should work on a label change that puts them on a category of inhaled or oral insulin (non injection insulin). Something that identifies the transport of insulin. If they can achieve that Afrezza will be the only one on that category and Novo and Lilly would be left with their pants down. Afrezza would be the leader in oral/inhale insulin. I doubt the ultra-fast or ultra-rapid will ever happen but the studies should identify that due to the way the insulin is taken with afrezza, hyperglycemia is not longer a critical issue. It already is labeled as inhaled. I don't think the FDA actually creates categories quite like you imagine. The FDA label certainly makes the route a prominent distinction... and MNKD can and does claim to be the only inhaled insulin. But whether doctors or payers give some significance to that is up to them, not the FDA.
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Post by drman7 on May 17, 2018 18:36:11 GMT -5
I believe Mannkind should work on a label change that puts them on a category of inhaled or oral insulin (non injection insulin). Something that identifies the transport of insulin. If they can achieve that Afrezza will be the only one on that category and Novo and Lilly would be left with their pants down. Afrezza would be the leader in oral/inhale insulin. I doubt the ultra-fast or ultra-rapid will ever happen but the studies should identify that due to the way the insulin is taken with afrezza, hyperglycemia is not longer a critical issue. It already is labeled as inhaled. I don't think the FDA actually creates categories quite like you imagine. The FDA label certainly makes the route a prominent distinction... and MNKD can and does claim to be the only inhaled insulin. But whether doctors or payers give some significance to that is up to them, not the FDA. Yes, we all now that but people have no clue there is an inhaled insulin which is my point. Right now Afrezza is mixed with the rest which I think the FDA does have a role.
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Post by mnholdem on May 17, 2018 18:44:06 GMT -5
It's a nice thought, but the classifications of insulin are based upon their PD/PK profile (e.g. speed of onset). I agree that it must be the ADA/AACE that creates a new category and define its place within its Living Standards of Care for diabetes.
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Post by sportsrancho on May 17, 2018 19:17:48 GMT -5
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Post by letitride on May 17, 2018 19:39:32 GMT -5
Not often I like every post in a thread but here it is a thumbs up to them all, and a special Thanks to all those that attended and posted here. AFREZZA to the Moon!
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Post by kc on May 17, 2018 19:46:55 GMT -5
sayhey24... to your #10, it seems bioexec is saying Kindall believes a label change to ultra-rapid can be achieved without additional trials. i wonder if that was already submitted to the fda. Stat and hypo data could likely support that. Perhaps it’s part of the quarantined information that he will present at ADA 2018
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Post by dreamboatcruise on May 17, 2018 20:17:51 GMT -5
It already is labeled as inhaled. I don't think the FDA actually creates categories quite like you imagine. The FDA label certainly makes the route a prominent distinction... and MNKD can and does claim to be the only inhaled insulin. But whether doctors or payers give some significance to that is up to them, not the FDA. Yes, we all now that but people have no clue there is an inhaled insulin which is my point. Right now Afrezza is mixed with the rest which I think the FDA does have a role. Route of delivery actually is a field used to categorize in FDA database and Afrezza certainly is in a different delivery route category. However, insurers/doctors/etc. are free to make their own determinations as to what context that has a clinical relevance. FDA isn't going to make that determination. Insurers are free to consider Afrezza as equivalent as long as it isn't medically necessary to make the distinction... and FDA isn't in the business of determining what is "medically necessary" for purposes of insurance, malpractice, etc. Right now insurers are lumping it in with RAAs with the exception of such circumstances as severe needle phobia... where the delivery route distinction becomes relevant. Even if/when Afrezza gets ultra-rapid as a descriptor (as it already has 'inhaled' as a descriptor) in labeling, the FDA doesn't control whether any third party would consider that significant enough to not mix Afrezza in a general meal-time vs basal classification scheme. [Caveat: This is my understanding based on what I've been told by people in pharma. It's not inherently my area of expertise, and info to confirm all of this is hard to find online.]
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Post by sayhey24 on May 17, 2018 20:28:23 GMT -5
If Dr. Kendall actually gets afrezza as the standard of care for both T1s and T2s does it matter if it is ultra, near-natural or just old-school rapid? Afrezza will be the only thing which will be used when it comes to the T2s and if cheap enough the only thing taken at meal time for the T1s.
Didn't he just say something about the greatest advance in insulin in 93 years? Since Banting and Best? Maybe the label should just say "Stop the Banting, its the Best".
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Post by uvula on May 17, 2018 20:53:34 GMT -5
Money talks and metfornin costs pennies per day. Insurances companies care more about cost than health. Will reduced complications offset the cost of afrezza? I don't know the answer.
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Post by sayhey24 on May 17, 2018 21:13:48 GMT -5
Uvula - not even Ralph DeFronzo believes in metformin any more. He calls it the biggest waste in diabetes care. The goal of the insurance companies is to spend the least amount and get the people to medicare. 70% of PWDs using metformin are not even at a 7 A1c. Even the ones which are see increased ldl, heart disease, eye issues, peripheral neuropathy and the list goes on. An A1c of 7.0 is an average BG of 154mg/dl of which they are probably spiking to 200+.
Do you still think metformin is cheap? Its costing the insurance companies a fortune and they know it. The only thing its doing is getting the new PWD out of the PCPs office in 30minutes with a script leading to a big mess. Their problem is they don't know how to fix the problem. Every big self insured company now has "health programs" to try to prevent T2. One thing they are also learning is these programs are not working and the T2 rate is rising.
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