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Post by brotherm1 on Apr 26, 2018 21:41:03 GMT -5
fast in, fast acting, fast out, end of continuum. Ultra rapid. Period.
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Post by mango on Apr 26, 2018 21:42:28 GMT -5
That's what I am thinking too. Afrezza and Aspart are both classified as rapid acting insulins so according to FDA they should both deliver similar results, correct? What STAT will reveal is that is incorrect: #1 Afrezza physiologically mimics endogenous human insulin secretion, it is not even "ultra rapid" it is simply providing the same insulin any other person without diabetes has and mimicking the first-phase release that is lost. Afrezza mimics human insulin because it is human insulin. Is does what insulin does because that's what it is and what it is suppose to do. #2 Aspart is not even insulin. Proline was taken out of the B28 position and replaced with aspartic acid which does not even exist in neither A nor B chains of human insulin amino acid sequences. It does not mimic insulin because it is not insulin. It is an altered foreign protein. STAT is real time evidence that Afrezza mimics endogenous insulin secretion. New drugs with better efficacy often are designated in the same class as older drugs that are less effective. I believe there would have to be some other reason justifying a new designation. In the case of speed of action in insulins it may be that a new designation would help with patient understanding and correct use of the product... that might be the compelling reason to create a new designation, but still the thorny issue is how does one draw the line when in reality the speed of action is a continuum. From FDA: Types of InsulinThere are many different types of insulin. The type lets you know how fast the insulin starts working or how long it lasts in your body. Your health care provider will help you find the insulin that is best for you.- Rapid-Acting - This insulin starts working within 15 minutes after you use it. It is mostly gone out of your body after a few hours. It should be taken just before or just after you eat.
www.fda.gov/forconsumers/byaudience/forwomen/womenshealthtopics/ucm216233.htm#typesAFREZZA® is a rapid acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. www.accessdata.fda.gov/drugsatfda_docs/label/2017/022472s011lbl.pdfFIASP (insulin aspart injection) is a rapid-acting insulin analog for subcutaneous or intravenous administration used to lower blood glucose. www.accessdata.fda.gov/drugsatfda_docs/label/2018/208751s001lbl.pdf |
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Post by mnholdem on Apr 26, 2018 22:44:55 GMT -5
From the San Fernando Business Journal - Thursday, April 26, 2018 MannKind previously was required to publish communications materials – including fact sheets handed out at scientific presentations as well as a dedicated website – detailing the risks Afrezza posed to patients with lung diseases. The mandate was part of a Risk Evaluation and Mitigation Strategy, or REMS, a plan that the FDA requires some drug companies to create in the process of the drug approval process.
No longer having to adhere to a REMS frees up MannKind sales representatives to espouse the benefits of Afrezza to physicians rather than having to spend time warning them about the risks...
Additionally, the development improves the perceived risk-benefit profile of the company’s proprietary Techosphere drug delivery platform, which MannKind can sell to other pharmaceutical firms.
Source: San Fernando Business Journal. sfvbj.com/news/2018/apr/25/mannkind-stock-jumps-fda-news/ --- MannKind has an entirely new website that is focused on communicating the benefits of using Afrezza Inhalable Insulin, which replaces the previous site whose focus was on communicating the risks as required by the FDA-mandated REMS plan. I expect a totally new Afrezza Physician's Site will also be launched very soon, perhaps within a week. In a similar fashion, the Afrezza sales force has an entirely new sales package for indoctrinating physicians, pharmacists and other health care professionals. I realize now that CEO Castagna's strategy has been to limit sales efforts to target areas until the cumbersome REMS plan was lifted by the FDA. Now, MannKind is free to market Afrezza in a big way.  Read more: mnkd.proboards.com/thread/8970/michael-kovacocy-mannkind-comments?page=35&scrollTo=145646#ixzz5DqCGQzZa |
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Post by mnholdem on Apr 26, 2018 22:53:47 GMT -5
With the shenanigans that happened at the FDA during the first and second CRLs and the fierce competition MannKind is facing from the established BPs, I would not tell a soul what I had up my sleeve. My hope is that the STAT study is sound enough along with all of the 60 or more older studies that they can apply to have the label upgraded to Ultra Fast Acting. We will see. They've already provided sound data on having the fastest pk/pd profile... and it was approved by FDA and included in prescribing lit. It's just that the FDA doesn't appear to yet want to define whether a new designation/class is needed and if so what the threshold for qualifying should be. I don't think any new data from STAT or otherwise would change whether/when FDA will decide on a new designation. It's not the STAT study or any open study that will convince the FDA to reverse it's ruling on the sNDA submitted by MannKind. It will be Dr. David Kendall, quite possibly with backing from the American Diabetes Association and other key opinion leaders. I'm also expecting a major medical journal publication about Afrezza within the next 3 months. |
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Post by digger on Apr 26, 2018 22:59:44 GMT -5
They've already provided sound data on having the fastest pk/pd profile... and it was approved by FDA and included in prescribing lit. It's just that the FDA doesn't appear to yet want to define whether a new designation/class is needed and if so what the threshold for qualifying should be. I don't think any new data from STAT or otherwise would change whether/when FDA will decide on a new designation. It's not the STAT study or any open study that will convince the FDA to reverse it's ruling on the sNDA submitted by MannKind. It will be Dr. David Kendall, quite possibly with backing from the American Diabetes Association and other key opinion leaders. I'm also expecting a major medical journal publication about Afrezza within the next 3 months. "a major medical journal publication about" with regards to what about afrezza? |
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Post by digger on Apr 26, 2018 23:13:17 GMT -5
From the San Fernando Business Journal - Thursday, April 26, 2018 MannKind previously was required to publish communications materials – including fact sheets handed out at scientific presentations as well as a dedicated website – detailing the risks Afrezza posed to patients with lung diseases. The mandate was part of a Risk Evaluation and Mitigation Strategy, or REMS, a plan that the FDA requires some drug companies to create in the process of the drug approval process.
No longer having to adhere to a REMS frees up MannKind sales representatives to espouse the benefits of Afrezza to physicians rather than having to spend time warning them about the risks...
Additionally, the development improves the perceived risk-benefit profile of the company’s proprietary Techosphere drug delivery platform, which MannKind can sell to other pharmaceutical firms.
Source: San Fernando Business Journal. sfvbj.com/news/2018/apr/25/mannkind-stock-jumps-fda-news/ --- MannKind has an entirely new website that is focused on communicating the benefits of using Afrezza Inhalable Insulin, which replaces the previous site whose focus was on communicating the risks as required by the FDA-mandated REMS plan. I expect a totally new Afrezza Physician's Site will also be launched very soon, perhaps within a week. In a similar fashion, the Afrezza sales force has an entirely new sales package for indoctrinating physicians, pharmacists and other health care professionals. I realize now that CEO Castagna's strategy has been to limit sales efforts to target areas until the cumbersome REMS plan was lifted by the FDA. Now, MannKind is free to market Afrezza in a big way. Read more: mnkd.proboards.com/thread/8970/michael-kovacocy-mannkind-comments?page=35&scrollTo=145646#ixzz5DqCGQzZaI disagree. Here is the REMS document -- www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472Orig1s000REMS.pdf -- and it says: "A REMS Factsheet will be distributed with the REMS Letter for Healthcare Providers and made available to healthcare providers through MannKind Corporation’s sales and medical representatives during the initial discussion with healthcare providers during the first 12 months after approval of this AFREZZA REMS. If the commercial launch of Afrezza occurs later than 90 days after REMS approval, distribution of the REMS Factsheet will continue during the initial discussion with healthcare providers during the first 18 months after approval of the REMS." Since the last "REMS modification was approved on April 20, 2015" the requirement for reps to mention REMS to doctors expired a long time ago around July of 2015. Similarly, it appears all the other requirements appear to have been met a long time ago as well." |
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Post by sayhey24 on Apr 27, 2018 5:37:05 GMT -5
Digger - it seems what happened was MNKD had already submitted an sNDA for "something" which included removal of the REMs and it was approved prior to 4/17. On 4/17 the FDA sent a notice about changes needed to the REMS communication plan because of "Government Streamlining". On 4/19 MNKD responded with a new sNDA saying "Hey - we don't need the REMS anymore per prior approval". On 4/24 the FDA said that is correct the REMS was already removed forget the communication plan.
Per the 4/24 letter "This Prior Approval sNDA (NDA 022472/S-017) provides for proposed modifications to the approved Afrezza risk evaluation and mitigation strategy (REMS). This supplement is in response to our April 17, 2018, REMS Modification Notification letter."
What we don't know is all of what was in the sNDA submitted and approved prior to 4/17. We will just have to wait and see. What we do know is the REMS is gone along with the required communication plan.
Bottom line - more to come, it could be interesting
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Post by golfeveryday on Apr 27, 2018 6:59:19 GMT -5
Digger - it seems what happened was MNKD had already submitted an sNDA for "something" which included removal of the REMs and it was approved prior to 4/17. On 4/17 the FDA sent a notice about changes needed to the REMS communication plan because of "Government Streamlining". On 4/19 MNKD responded with a new sNDA saying "Hey - we don't need the REMS anymore per prior approval". On 4/24 the FDA said that is correct the REMS was already removed forget the communication plan. Per the 4/24 letter "This Prior Approval sNDA (NDA 022472/S-017) provides for proposed modifications to the approved Afrezza risk evaluation and mitigation strategy (REMS). This supplement is in response to our April 17, 2018, REMS Modification Notification letter." What we don't know is all of what was in the sNDA submitted and approved prior to 4/17. We will just have to wait and see. What we do know is the REMS is gone along with the required communication plan. Bottom line - more to come, it could be interesting if there was anything material they would have to announce it. What’s your thoughts on what could be in there that they could sit on? |
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Post by digger on Apr 27, 2018 8:19:49 GMT -5
Digger - it seems what happened was MNKD had already submitted an sNDA for "something" which included removal of the REMs and it was approved prior to 4/17. On 4/17 the FDA sent a notice about changes needed to the REMS communication plan because of "Government Streamlining". On 4/19 MNKD responded with a new sNDA saying "Hey - we don't need the REMS anymore per prior approval". On 4/24 the FDA said that is correct the REMS was already removed forget the communication plan. Per the 4/24 letter "This Prior Approval sNDA (NDA 022472/S-017) provides for proposed modifications to the approved Afrezza risk evaluation and mitigation strategy (REMS). This supplement is in response to our April 17, 2018, REMS Modification Notification letter." What we don't know is all of what was in the sNDA submitted and approved prior to 4/17. We will just have to wait and see. What we do know is the REMS is gone along with the required communication plan. Bottom line - more to come, it could be interesting Per the FDA website regarding the REMS requirement: "Timetable for assessments must be at least by 18 months, 3 years, and in the 7th year after the REMS is approved Can be eliminated after 3 years" The letter Mannkind received said: "Please refer to your supplemental New Drug Application (sNDA) dated and received April 19, 2018, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Afrezza (insulin human) inhalation powder. This Prior Approval sNDA provides for proposed modifications to the approved Afrezza risk evaluation and mitigation strategy (REMS). This supplement is in response to our April 17, 2018, REMS Modification Notification letter. We have completed our review of this supplemental application." I think on April 17 the FDA noted to Mannkind the possibility, now that 3 years had passed, of "modifying" -- i.e. removing -- removing the REMS and on April 19, Mannkind requested such -- no more, no less. |
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Post by agedhippie on Apr 27, 2018 8:25:45 GMT -5
Digger - it seems what happened was MNKD had already submitted an sNDA for "something" which included removal of the REMs and it was approved prior to 4/17. On 4/17 the FDA sent a notice about changes needed to the REMS communication plan because of "Government Streamlining". On 4/19 MNKD responded with a new sNDA saying "Hey - we don't need the REMS anymore per prior approval". On 4/24 the FDA said that is correct the REMS was already removed forget the communication plan. Per the 4/24 letter "This Prior Approval sNDA (NDA 022472/S-017) provides for proposed modifications to the approved Afrezza risk evaluation and mitigation strategy (REMS). This supplement is in response to our April 17, 2018, REMS Modification Notification letter." What we don't know is all of what was in the sNDA submitted and approved prior to 4/17. We will just have to wait and see. What we do know is the REMS is gone along with the required communication plan. Bottom line - more to come, it could be interesting if there was anything material they would have to announce it. What’s your thoughts on what could be in there that they could sit on? The FDA requires REMS progress reports at the 18 month, 3 year, and 7 year marks. The FDA sent a letter on April 17, 2018 saying, hey, your 3 year report is due (it's been 3 years since the plan was approved) and can you tell us how the execution of the plan is going? Mannkind responded on April, 19 saying it's complete. FDA then say great, in that case the REMS is complete and so there is no point in sending a report at the 7 year mark. A couple of things. Any communication concerning the status of an approval whether it's a logo on a box, changing the composition of the drug, or responding to a REMS letter is an sNDA because it modifies the state of the approval package. The other thing is that a response is single threaded - an sNDA, contrary to what people might think, covers only the topic in hand. The sNDA for the REMS will just say the plan is complete, that's all that is required and the golden rule with regulators is answer the question with the minimum of information. In this case the question is if the REMS is complete, the answer to that question is yes, and not yes and here is a load of stuff that we think is cool. Third thing (I lied when I said there were two  ) is that the simplest answer is usually the correct one. In this case Mannkind simply said the REMS was complete. If there is data on hand from trials that would be material to a label change that will be submitted (may already have been submitted) as a separate sNDA. |
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Post by mnholdem on Apr 27, 2018 10:07:09 GMT -5
You are correct, sir.
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Post by goyocafe on Apr 27, 2018 10:40:10 GMT -5
//The Afrezza website, www.afrezzarems.com, will be inactivated, and the Company will no longer be required to distribute the Afrezza fact sheet at scientific meetings.// Looks like that may be it for now as to the action of MNKD. More to follow. OK, MNKD, change Afrezzarems.com page to include a copy of the letter and explanation, clear all the other content, and move on. It looks like they killed the website. Seems it would have been better to revise the content, as noted above, and add some back links to Afrezza.com and Mannkind (can help with search engine optimization). |
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Post by dreamboatcruise on Apr 27, 2018 12:06:23 GMT -5
They've already provided sound data on having the fastest pk/pd profile... and it was approved by FDA and included in prescribing lit. It's just that the FDA doesn't appear to yet want to define whether a new designation/class is needed and if so what the threshold for qualifying should be. I don't think any new data from STAT or otherwise would change whether/when FDA will decide on a new designation. It's not the STAT study or any open study that will convince the FDA to reverse it's ruling on the sNDA submitted by MannKind. It will be Dr. David Kendall, quite possibly with backing from the American Diabetes Association and other key opinion leaders. I'm also expecting a major medical journal publication about Afrezza within the next 3 months. Novo as well is likely pushing to have a new designation, of course defined such that Fiasp qualifies. If the ADA were to weigh in on this, that might carry weight with the FDA. As I learned long ago, trying to predict what and when the FDA does things seems to be a fools errand. My point is simply that the speed of Afrezza has already been proven and accepted by the FDA... as demonstrated by Peppy often posting the PD table in Afrezza lit compared to the one in Fiasp lit. Personally, It isn't clear to me that being called "ultra-rapid" would really change much, unless as some have suggested, it would change how insurance formularies treat Afrezza. The table already makes it pretty clear to patients and doctors that Afrezza is far faster than other prandials. |
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Post by zuegirdor on Apr 27, 2018 13:16:43 GMT -5
From the San Fernando Business Journal - Thursday, April 26, 2018 MannKind previously was required to publish communications materials – including fact sheets handed out at scientific presentations as well as a dedicated website – detailing the risks Afrezza posed to patients with lung diseases. The mandate was part of a Risk Evaluation and Mitigation Strategy, or REMS, a plan that the FDA requires some drug companies to create in the process of the drug approval process.
No longer having to adhere to a REMS frees up MannKind sales representatives to espouse the benefits of Afrezza to physicians rather than having to spend time warning them about the risks...
Additionally, the development improves the perceived risk-benefit profile of the company’s proprietary Techosphere drug delivery platform, which MannKind can sell to other pharmaceutical firms.
Source: San Fernando Business Journal. sfvbj.com/news/2018/apr/25/mannkind-stock-jumps-fda-news/ --- MannKind has an entirely new website that is focused on communicating the benefits of using Afrezza Inhalable Insulin, which replaces the previous site whose focus was on communicating the risks as required by the FDA-mandated REMS plan. I expect a totally new Afrezza Physician's Site will also be launched very soon, perhaps within a week. In a similar fashion, the Afrezza sales force has an entirely new sales package for indoctrinating physicians, pharmacists and other health care professionals. I realize now that CEO Castagna's strategy has been to limit sales efforts to target areas until the cumbersome REMS plan was lifted by the FDA. Now, MannKind is free to market Afrezza in a big way. Read more: mnkd.proboards.com/thread/8970/michael-kovacocy-mannkind-comments?page=35&scrollTo=145646#ixzz5DqCGQzZaI hope you are right. Son's new endo did not have any problem with the REM or pulmonary risk (none). He only mentioned price as a concern. And that it is not covered by our plan. Still waiting for word on his efforts...meanwhile I am swinging for the next box at $600 out of pocket thanks to the coupon. But he needs closer to a box and a half to get through the month. |
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Post by alethea on Apr 27, 2018 13:46:09 GMT -5
I hope you are right. Son's new endo did not have any problem with the REM or pulmonary risk (none). He only mentioned price as a concern. And that it is not covered by our plan. Still waiting for word on his efforts... meanwhile I am swinging for the next box at $600 out of pocket thanks to the coupon. But he needs closer to a box and a half to get through the month. I just paid $829.56 for ONE box of 180 cartridges (previously had incorrectly said $816). I'm in Medicare in a couple months with absolutely NO COVERAGE whatsoever. Afrezza NOT on the formulary of ANY plan Medicare Supplement Plan available in my part of the state. A box and a half will cost me about $1,200. Clever marketing Mike. Nice job. You are only excluding the biggest segment of Type 2's in the entire country (Medicare participants). Nice move. And thanks for helping diabetics. Al would be so pleased. |
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) is that the simplest answer is usually the correct one. In this case Mannkind simply said the REMS was complete.
