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Post by sophie on Apr 29, 2018 21:56:56 GMT -5
I can't recall if anyone brought up gestational diabetes on this forum or not. This seems like a great patient population to go after because it's an acquired metabolic disease- mom's aren't used to poking themselves, and the main focus is on post-prandial control. No metformin, straight to insulin. I think I remembered reading that Afrezza was on the formulary for most medicaid programs. If not, they should be. It seems like medicaid programs should be easier to get on... maybe not considering the difficulty with medicare programs. This is really one niche market that they should have absolutely no competition since insulin is the first and only line of treatment.
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Post by tinkusr8215 on Apr 30, 2018 13:53:05 GMT -5
I am not sure if there are any studies done with Afrezza during pregnancy. It might be the standard "Ask your doctor"
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Post by digger on Apr 30, 2018 17:14:39 GMT -5
I can't recall if anyone brought up gestational diabetes on this forum or not. This seems like a great patient population to go after because it's an acquired metabolic disease- mom's aren't used to poking themselves, and the main focus is on post-prandial control. No metformin, straight to insulin. I think I remembered reading that Afrezza was on the formulary for most medicaid programs. If not, they should be. It seems like medicaid programs should be easier to get on... maybe not considering the difficulty with medicare programs. This is really one niche market that they should have absolutely no competition since insulin is the first and only line of treatment. "8.1 Pregnancy Teratogenic Effects: Pregnancy Category C AFREZZA has not been studied in pregnant women. AFREZZA should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus." |
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Post by sophie on Apr 30, 2018 18:07:07 GMT -5
I hope this is an area of focus for MNKD once (if) they get enough money to run trials. Easy to play armchair quarterback, but this seems like it should have been low-hanging fruit and should have been one of the first priorities. After all, pregnant woman also change their lung physiology while pregnant and are more dependent on their lung's health to maintain a viable pregnancy. Could have killed 2 birds with one stone IMO.
I'm curious if we'll ever know just how bad of shape the company was prior to MC taking over. You'd never guess it from Hakan/Matt, but MC seems to paint a pretty bleak portrait of the past. It doesn't take a genius to see all the progress that has been made, but it's also concerning that the progress that matters hasn't happened yet... So while the tree is (hopefully) no longer rotting on the inside, how much longer will it be before it's healthy enough to bear fruit?
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Post by digger on Apr 30, 2018 19:37:36 GMT -5
I hope this is an area of focus for MNKD once (if) they get enough money to run trials. Easy to play armchair quarterback, but this seems like it should have been low-hanging fruit and should have been one of the first priorities. After all, pregnant woman also change their lung physiology while pregnant and are more dependent on their lung's health to maintain a viable pregnancy. Could have killed 2 birds with one stone IMO. I'm curious if we'll ever know just how bad of shape the company was prior to MC taking over. You'd never guess it from Hakan/Matt, but MC seems to paint a pretty bleak portrait of the past. It doesn't take a genius to see all the progress that has been made, but it's also concerning that the progress that matters hasn't happened yet... So while the tree is (hopefully) no longer rotting on the inside, how much longer will it be before it's healthy enough to bear fruit? Per www.ncbi.nlm.nih.gov/pmc/articles/PMC4509429/ -- "It is estimated that 70–85% of cases can be controlled with lifestyle modifications alone" and "ACOG states that insulin and oral agents are equally efficacious and either can be used first line while NICE recommends metformin over insulin therapy." There likely wouldn't be much low hanging fruit left on the tree or even high hanging fruit for that matter. |
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Post by sayhey24 on Apr 30, 2018 19:42:02 GMT -5
If I remember the discussion at the ADCOM correctly, the concern raised was that of FDKP affecting the baby. I am not sure its a viable concern but it was raised by the same crowd talking up Exubera and lung cancer. Three years later we see few if any having any lung issues and some reporting better FEV1 results.
In early 2016 when Mike showed up MNKD was in bad shape. They just lost the sales deal with SNY (which may actually be a blessing), the announced new CEO quit before he started, the founder and genius just past and the new substitute CEO had health issues.
While I like Mike, let face it, in 2 years he has yet to close a sales deal. However, he may have even closed a bigger deal and that was landing Dr. Kendall. IMO, prior to Dr. Kendall showing up MNKD was like a ship without a rudder. While Mike keep it afloat, Dr. Kendall has given it direction.
This time last year things were really bad and I was not sure it would still be intact in April 2018. Now I think within the next 2 month we could see some major announcements.
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Post by sportsrancho on Apr 30, 2018 19:43:49 GMT -5
I hope this is an area of focus for MNKD once (if) they get enough money to run trials. Easy to play armchair quarterback, but this seems like it should have been low-hanging fruit and should have been one of the first priorities. After all, pregnant woman also change their lung physiology while pregnant and are more dependent on their lung's health to maintain a viable pregnancy. Could have killed 2 birds with one stone IMO. I'm curious if we'll ever know just how bad of shape the company was prior to MC taking over. You'd never guess it from Hakan/Matt, but MC seems to paint a pretty bleak portrait of the past. It doesn't take a genius to see all the progress that has been made, but it's also concerning that the progress that matters hasn't happened yet... So while the tree is (hopefully) no longer rotting on the inside, how much longer will it be before it's healthy enough to bear fruit? We have somebody running the company now that visualizes Afrezza becoming the standard of care. That was the real missing piece. |
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Post by sophie on Apr 30, 2018 19:46:01 GMT -5
It looks like the guidelines might slowly be changing then. Missed opportunity. Used to be insulin only if unable to control with diet/exercise.
I doubt it would take much work to become standard of care if they could complete a safety trial. Glyburide and metformin are not good prandial options and GD rightly focuses on post-prandial glucose (as should all) over A1c
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Post by sayhey24 on Apr 30, 2018 19:54:59 GMT -5
The simple answer should be afrezza. In time it will be. Old school thinking of attempting to control with just diet are not worth the risk when the risk of severe hypos when using afrezza without a basal are close to zero. All antiglycemics are the wrong answer.
I suspect Dr. Kendall has this on his to do list.
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Post by liane on Apr 30, 2018 20:24:34 GMT -5
If I remember the discussion at the ADCOM correctly, the concern raised was that of FDKP affecting the baby. I am not sure its a viable concern but it was raised by the same crowd talking up Exubera and lung cancer. Three years later we see few if any having any lung issues and some reporting better FEV1 results. There was an OB/Gyn at ADCOM advocating for the use of Afrezza in her pregnant patients. Don't recall her name or the specifics. |
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Post by brentie on Apr 30, 2018 22:02:34 GMT -5
If I remember the discussion at the ADCOM correctly, the concern raised was that of FDKP affecting the baby. I am not sure its a viable concern but it was raised by the same crowd talking up Exubera and lung cancer. Three years later we see few if any having any lung issues and some reporting better FEV1 results. There was an OB/Gyn at ADCOM advocating for the use of Afrezza in her pregnant patients. Don't recall her name or the specifics. |
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Post by liane on May 1, 2018 3:51:29 GMT -5
brentie - You're awesome!!! She was an endo, not an OB/Gyn, but still - lots of pregnant pts. Her testimony was very convincing.
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Post by matt on May 1, 2018 6:55:37 GMT -5
It might not make sense to invest precious dollars in going after this population. While it is unfortunate that some women have this condition during pregnancy, onset of gestational diabetes it is almost always a third trimester event that self-corrects when the baby is born. That would mean a significant sales effort to obtain patients that will be on therapy for less than 90 days. Given the low penetration in Type I and Type II diabetic populations, a continued focus on those populations would be a far better investment. That is not to say that the affected women could not benefit from the drug, but this is not a business priority for a company bleeding cash.
Since Afrezza needs careful titration and patient education, I wonder if the physicians will simply decide that it is too complicated a regimen given the need to get glucose under control rapidly. By the time the patient is properly trained and the medication adequately titrated the pregnancy, and need for supplemental insulin, may well be over.
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Post by liane on May 1, 2018 7:19:29 GMT -5
So many drugs are not investigated in the pregnant population for this and other reasons (pregnancy category B - no problems in animals, not studied in pregnant women). Ultimately, it's a physician judgement call whether potential benefit outweighs potential risk.
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Post by sophie on May 1, 2018 13:35:30 GMT -5
It might not make sense to invest precious dollars in going after this population. While it is unfortunate that some women have this condition during pregnancy, onset of gestational diabetes it is almost always a third trimester event that self-corrects when the baby is born. That would mean a significant sales effort to obtain patients that will be on therapy for less than 90 days. Given the low penetration in Type I and Type II diabetic populations, a continued focus on those populations would be a far better investment. That is not to say that the affected women could not benefit from the drug, but this is not a business priority for a company bleeding cash. Since Afrezza needs careful titration and patient education, I wonder if the physicians will simply decide that it is too complicated a regimen given the need to get glucose under control rapidly. By the time the patient is properly trained and the medication adequately titrated the pregnancy, and need for supplemental insulin, may well be over. I agree with what you're saying. I meant more so for safety trials. The physiology of the maternal lung changes after pregnancy. It makes sense (to me anyway) to target this group because mothers would show lung changes more quickly and easily than other populations. I suppose there wouldn't be much benefit versus COPD populations (another physiological changed population)- they are much more prevalent- but you could do a pregnancy study at the same time to kill 2 birds with one stone. I don't design trials and maybe I'm being critical in my ignorance. If I was the one calling the shots- and maybe it's best I'm not- I would be sure to include gestational diabetes as a subset. |
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