|
|
Post by peppy on Apr 28, 2018 12:04:53 GMT -5
I see a MNKD referred endo on May 4 to try and get started on Afrezza, and plan to document my experience(s) to the board. We'll see if those tests are still required. Denise, your blood glucose levels are running high? I look forward to hearing your experiences. |
|
|
|
Post by sayhey24 on Apr 28, 2018 14:09:12 GMT -5
Digger - I thought the same as you and assumed both spirometery and black are still needed. However then I started reading the REMS info. I can't find anywhere else aside from the REMS these were required. If the REMS is gone it seems the REMS requirements are gone too. The 5 day approval of the sDNA also seemed very odd. Maybe its not but 5 days seems unusual like they had already been working with MNKD on something else. If another sNDA which was marked "confidential" had already been submitted with the data justifying the REMS is no longer needed then the 4/24 5 day approval makes sense. If so its probably as simply as an oversight and MNKD did not check the box to keep the 4/19 sNDA confidential, so it leaked. Clearly MNKD did not seem prepared to issue the PR on 4/24 nor 4/25 when it came out after hours. At this point I am going to believe my theory is correct because it would be better news than the original approval and believing this through the weekend will make me happy. If you can point to a document where the spirometry is required aside from the REMS, let me know and I will come back to reality. Sey, are you saying neither the spirometry or black box are in the label? Section 5.1 and 5.4 seem to call out both the bronchospasm (Black box) and spirometry respectively. Help me understand, please. I would like to share your enthusiasm. Yes, sections 5.1 and 5.4 are as you say. What I am saying is the only place I can find that requires 5.1 and 5.4 on the label is in the REMS. If the REMS is gone it would seem all the required actions in the REMS are gone and 5.1 and 5.4 could be removed from the label. I have asked Digger several times where else these 2 requirements are documented as being required and he/she provides a circular response that the black box requires the spirometry and the black box is required just because it is. I think he said "think about it". I think it is probable the warning of bronchospasm will still be on the new label but not in a black box. I could also see spirometery being recommended but not required. To change the current label to remove sections 5.1 and 5.4 will take another sNDA. However, to remove those sections would require them to be first removed from the current REMS or end the REMS. In this case the REMS was ended. While possible it seems highly unusual the FDA just ended the REMS without MNKD providing data demonstrating afrezza benefits out weight its risk. The FDA taking Dr. Kendall at his word without data seems odd along with an sNDA 5 day approval. How could they review the data, bring it before the FDA panel and get the sign-off in 5 days? It probably takes at least 2 weeks to get on the internal review panel calendar. Which leads me to ask the question, was another sNDA already in the works or possibly already approved but marked "confidential". With the ASM and ADA2018 coming up holding the PR would seem to make marketing sense, especially if a partnership PR was released right after. I know Trump talked about streamlining the FDA but 5 days for an sNDA approval is beyond streamlining. Its amazing. |
|
|
|
Post by peppy on Apr 28, 2018 15:09:35 GMT -5
Sey, are you saying neither the spirometry or black box are in the label? Section 5.1 and 5.4 seem to call out both the bronchospasm (Black box) and spirometry respectively. Help me understand, please. I would like to share your enthusiasm. Yes, sections 5.1 and 5.4 are as you say. What I am saying is the only place I can find that requires 5.1 and 5.4 on the label is in the REMS. If the REMS is gone it would seem all the required actions in the REMS are gone and 5.1 and 5.4 could be removed from the label. I have asked Digger several times where else these 2 requirements are documented as being required and he/she provides a circular response that the black box requires the spirometry and the black box is required just because it is. I think he said "think about it". I think it is probable the warning of bronchospasm will still be on the new label but not in a black box. I could also see spirometery being recommended but not required. To change the current label to remove sections 5.1 and 5.4 will take another sNDA. However, to remove those sections would require them to be first removed from the current REMS or end the REMS. In this case the REMS was ended. While possible it seems highly unusual the FDA just ended the REMS without MNKD providing data demonstrating afrezza benefits out weight its risk. The FDA taking Dr. Kendall at his word without data seems odd along with an sNDA 5 day approval. How could they review the data, bring it before the FDA panel and get the sign-off in 5 days? It probably takes at least 2 weeks to get on the internal review panel calendar. Which leads me to ask the question, was another sNDA already in the works or possibly already approved but marked "confidential". With the ASM and ADA2018 coming up holding the PR would seem to make marketing sense, especially if a partnership PR was released right after. I know Trump talked about streamlining the FDA but 5 days for an sNDA approval is beyond streamlining. Its amazing. Say Hey, I love you! Nice work. No one will tell us better us then Kendall. mango, I will pay for your uber/taxi from LAX to the Hotel!. Weehaw Report |
|
|
|
Post by peppy on Apr 28, 2018 15:14:18 GMT -5
Not only that, We can see. Look at the new website, no black box. As you said, "stated." Important safety information. No black box. afrezza.comMNKD was ready for this. They are starting the engines. ADA will be good. Compare and contrast, www.trulicity.com/healthcare-professionals/?srcid=trusem_google_trulicity&WT.srch=1&WT.mc_id=71700000025139262-58700003129178117-43700024531788212&gclid=CNm7rbrl3doCFRirswod0qEPAw&gclsrc=ds&dclid=CIeHxbrl3doCFay4swodkZcEtAEli Lilly Trulicity still has it's black box. WARNING: RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutide causes a dose‑related and treatment-duration-dependent increase in the incidence of thyroid C‑cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C‑cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide‑induced rodent thyroid C‑cell tumors has not been determined. Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity. Afrezza and Trulicity cost the same. prnt.sc/j7x5ka |
|
|
|
Post by agedhippie on Apr 28, 2018 16:12:58 GMT -5
There is some confusion over what constitutes a black box warning. A black box warning is required verbatim only on the prescribing information where is must be surrounded by a black box. In adverts and web sites the most important risks can be paraphrased, but they must be presented in the main part of the page, lesser risks can be hidden. This is what you see in the Afrezza site with the black box risk in a floating box anchored at the bottom of the screen so it is always visible, and the lesser risks hidden behind the ' +'. The always present information representing the black box risk is shown below (their emphasis): Important Safety Information for Afrezza (insulin human) Inhalation Powder
What is the most important information I should know about Afrezza? Afrezza can cause serious side effects, including: Sudden lung problems (bronchospasms). Do not use Afrezza if you have long-term (chronic) lung problems such as asthma or chronic obstructive pulmonary disease (COPD). Before starting Afrezza, your healthcare provider will give you a breathing test to check how your lungs are working.
If you click on the + symbol it expands to new page, Important Safety Information, and right at the top front and center it says (again their emphasis): Afrezza can cause serious side effects, including:
Sudden lung problems (bronchospasms). Do not use Afrezza if you have long-term (chronic) lung problems such as asthma or chronic obstructive pulmonary disease (COPD). Before starting Afrezza, your healthcare provider will give you a breathing test to check how your lungs are working.The lesser warning information is collapsed, but the part above cannot be collapsed because it is an important risk. Does the Afrezza site look better than the Trulicity site? Absolutely! But that is web site design, not a change to the black box. |
|
|
|
Post by peppy on Apr 28, 2018 16:20:10 GMT -5
There is some confusion over what constitutes a black box warning. A black box warning is required verbatim only on the prescribing information where is must be surrounded by a black box. In adverts and web sites the most important risks can be paraphrased, but they must be presented in the main part of the page, lesser risks can be hidden. This is what you see in the Afrezza site with the black box risk in a floating box anchored at the bottom of the screen so it is always visible, and the lesser risks hidden behind the ' +'. The always present information representing the black box risk is shown below (their emphasis): Important Safety Information for Afrezza (insulin human) Inhalation Powder
What is the most important information I should know about Afrezza? Afrezza can cause serious side effects, including: Sudden lung problems (bronchospasms). Do not use Afrezza if you have long-term (chronic) lung problems such as asthma or chronic obstructive pulmonary disease (COPD). Before starting Afrezza, your healthcare provider will give you a breathing test to check how your lungs are working.
If you click on the + symbol it expands to new page, Important Safety Information, and right at the top front and center it says (again their emphasis): Afrezza can cause serious side effects, including:
Sudden lung problems (bronchospasms). Do not use Afrezza if you have long-term (chronic) lung problems such as asthma or chronic obstructive pulmonary disease (COPD). Before starting Afrezza, your healthcare provider will give you a breathing test to check how your lungs are working.The lesser warning information is collapsed, but the part above cannot be collapsed because it is an important risk. Does the Afrezza site look better than the Trulicity site? Absolutely! But that is web site design, not a change to the black box. Thank you aged. I see what you are saying. So spirometry still there. I be fair, Trulicity site I posted prior was the label. a fair compare contrast, the website. www.trulicity.comBlack box still on the afrezza HCP site. hcp.afrezza.com/hcp/ |
|
|
|
Post by agedhippie on Apr 28, 2018 16:55:05 GMT -5
Thank you aged. I see what you are saying. So spirometry still there. I be fair, Trulicity site I posted prior was the label. a fair compare contrast, the website. www.trulicity.comBlack box still on the afrezza HCP site. hcp.afrezza.com/hcp/You are quite right about the Trulicity site. I looked at it and the warning is nowhere near as well designed as on the Afrezza web site. |
|
|
|
Post by mytakeonit on Apr 28, 2018 17:17:27 GMT -5
peppy - to be truly fair ... since you will pay for mango's uber/taxi ride ... will you pay for my flight from Japan and back so I can rejoin my family after this event?
I mean ... just to be fair.
|
|
|
|
Post by ilovekauai on Apr 28, 2018 20:52:56 GMT -5
Peppy: No.
A1c is 5.4 I used to be much higher, (8.0), but my diet/exercise life changes, (sadly quitting drinking being one), and I have this demon by the throat. I'm still funny though, as I'll pretend drink with you all in a few weeks to prove it!
I'm currently on 500 mg of Metformin, 4x per day, 2 mg per day of Glimiperide, and Bydureon, (which is expensive yet covered!). That's a lot of meds for what? I already know that I spike at meals so why not just flat line there with Afrezza and end of story?
So the plan when meeting with my new "pro-Afrezza," endo, is to scope this out and see if we can dump all my meds and just use Afrezza for when I eat my meals. I should be good to go with just that, but we'll see.
|
|
|
|
Post by cjm18 on Apr 28, 2018 20:59:45 GMT -5
Peppy: No. A1c is 5.4 I used to be much higher, (8.0), but my diet/exercise life changes, (sadly quitting drinking being one), and I have this demon by the throat. I'm still funny though, as I'll pretend drink with you all in a few weeks to prove it! I'm currently on 500 mg of Metformin, 4x per day, 2 mg per day of Glimiperide, and Bydureon, (which is expensive yet covered!). That's a lot of meds for what? I already know that I spike at meals so why not just flat line there with Afrezza and end of story? So the plan when meeting with my new "pro-Afrezza," endo, is to scope this out and see if we can dump all my meds and just use Afrezza for when I eat my meals. I should be good to go with just that, but we'll see. Good luck! Looking forward to hearing how pro he/she is. What % of endos would want to change anything with that a1c? |
|
|
|
Post by ilovekauai on Apr 28, 2018 21:07:09 GMT -5
Not many I agree, however the Bydureon is expensive so maybe it be easy to switch out? I'll try my best to get on Afrezza!
|
|
|
|
Post by digger on Apr 28, 2018 21:30:38 GMT -5
Yes, sections 5.1 and 5.4 are as you say. What I am saying is the only place I can find that requires 5.1 and 5.4 on the label is in the REMS. If the REMS is gone it would seem all the required actions in the REMS are gone and 5.1 and 5.4 could be removed from the label. I have asked Digger several times where else these 2 requirements are documented as being required and he/she provides a circular response that the black box requires the spirometry and the black box is required just because it is. I think he said "think about it". I think it is probable the warning of bronchospasm will still be on the new label but not in a black box. I could also see spirometery being recommended but not required. To change the current label to remove sections 5.1 and 5.4 will take another sNDA. However, to remove those sections would require them to be first removed from the current REMS or end the REMS. In this case the REMS was ended. While possible it seems highly unusual the FDA just ended the REMS without MNKD providing data demonstrating afrezza benefits out weight its risk. The FDA taking Dr. Kendall at his word without data seems odd along with an sNDA 5 day approval. How could they review the data, bring it before the FDA panel and get the sign-off in 5 days? It probably takes at least 2 weeks to get on the internal review panel calendar. Which leads me to ask the question, was another sNDA already in the works or possibly already approved but marked "confidential". With the ASM and ADA2018 coming up holding the PR would seem to make marketing sense, especially if a partnership PR was released right after. I know Trump talked about streamlining the FDA but 5 days for an sNDA approval is beyond streamlining. Its amazing. Say Hey, I love you! Nice work. No one will tell us better us then Kendall. mango , I will pay for your uber/taxi from LAX to the Hotel!. Weehaw Report Please review "agehippie"'s comment about six posts ago and if you don't believe him, email Mannkind and ask them. |
|
|
|
Post by peppy on Apr 29, 2018 0:35:23 GMT -5
Say Hey, I love you! Nice work. No one will tell us better us then Kendall. mango , I will pay for your uber/taxi from LAX to the Hotel!. Weehaw Report Please review "agehippie"'s comment about six posts ago and if you don't believe him, email Mannkind and ask them. Digger I am drunk. hahahaha |
|
|
|
Post by peppy on Apr 29, 2018 0:38:03 GMT -5
Peppy: No. A1c is 5.4 I used to be much higher, (8.0), but my diet/exercise life changes, (sadly quitting drinking being one), and I have this demon by the throat. I'm still funny though, as I'll pretend drink with you all in a few weeks to prove it! I'm currently on 500 mg of Metformin, 4x per day, 2 mg per day of Glimiperide, and Bydureon, (which is expensive yet covered!). That's a lot of meds for what? I already know that I spike at meals so why not just flat line there with Afrezza and end of story? So the plan when meeting with my new "pro-Afrezza," endo, is to scope this out and see if we can dump all my meds and just use Afrezza for when I eat my meals. I should be good to go with just that, but we'll see. Jeez louise. you go girl. I await your report. |
|
|
|
Post by digger on Apr 29, 2018 1:30:15 GMT -5
Sey, are you saying neither the spirometry or black box are in the label? Section 5.1 and 5.4 seem to call out both the bronchospasm (Black box) and spirometry respectively. Help me understand, please. I would like to share your enthusiasm. Yes, sections 5.1 and 5.4 are as you say. What I am saying is the only place I can find that requires 5.1 and 5.4 on the label is in the REMS. If the REMS is gone it would seem all the required actions in the REMS are gone and 5.1 and 5.4 could be removed from the label. I have asked Digger several times where else these 2 requirements are documented as being required and he/she provides a circular response that the black box requires the spirometry and the black box is required just because it is. I think he said "think about it". I think it is probable the warning of bronchospasm will still be on the new label but not in a black box. I could also see spirometery being recommended but not required. To change the current label to remove sections 5.1 and 5.4 will take another sNDA. However, to remove those sections would require them to be first removed from the current REMS or end the REMS. In this case the REMS was ended. While possible it seems highly unusual the FDA just ended the REMS without MNKD providing data demonstrating afrezza benefits out weight its risk. The FDA taking Dr. Kendall at his word without data seems odd along with an sNDA 5 day approval. How could they review the data, bring it before the FDA panel and get the sign-off in 5 days? It probably takes at least 2 weeks to get on the internal review panel calendar. Which leads me to ask the question, was another sNDA already in the works or possibly already approved but marked "confidential". With the ASM and ADA2018 coming up holding the PR would seem to make marketing sense, especially if a partnership PR was released right after. I know Trump talked about streamlining the FDA but 5 days for an sNDA approval is beyond streamlining. Its amazing. Please review "agehippie"'s comment about 10-11 posts ago and if you don't believe him, email Mannkind and ask them. |
|
