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Post by robbmo on Apr 24, 2018 15:33:08 GMT -5
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Post by cjm18 on Apr 24, 2018 15:42:49 GMT -5
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Post by goyocafe on Apr 24, 2018 15:55:10 GMT -5
Could this precede removing the black box warning on the label?
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Post by cjm18 on Apr 24, 2018 15:57:29 GMT -5
Sounds like mannkind doesn’t have to send letters out to practitioners and no impact on label. But I hope I’m wrong.
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Post by robbmo on Apr 24, 2018 15:57:35 GMT -5
Could this precede removing the black box warning on the label? I believe that is exactly what this means... |
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Post by sportsrancho on Apr 24, 2018 17:11:25 GMT -5
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Post by thekindaguyiyam on Apr 24, 2018 17:24:16 GMT -5
SO. Technosphere gets a Thumbs Up. This is much bigger than just Afrezza news.
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Post by sayhey24 on Apr 24, 2018 17:25:32 GMT -5
Could this precede removing the black box warning on the label? I believe that is exactly what this means... Intersting, you guys could be right. Lets hope. I would be nice to get the spirometry test dropped too. |
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Post by goyocafe on Apr 24, 2018 17:27:09 GMT -5
I believe that is exactly what this means... Intersting, you guys could be right. Lets hope. I would be nice to get the spirometry test dropped too. After all, how would it look if the new standard of care had a black box warning on it? |
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Post by mango on Apr 24, 2018 17:27:32 GMT -5
Communication Plan:
We have determined that the communication plan is no longer necessary as an element of the REMS to ensure the benefits of Afrezza (insulin human) inhalation powder outweigh its risks because the communication plan has been completed and the most recent assessment demonstrated that the communication plan has met its goals. No further assessments are necessary to assess the current communication plan.
Therefore, because the communication plan is no longer necessary to ensure the benefits of the drug outweigh the risks, a REMS is no longer required for Afrezza (insulin human) inhalation powder.
REQUIRED PEDIATRIC ASSESSMENTS
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients REQUIRED PEDIATRIC ASSESSMENTS
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients (which includes new salts and new fixed combinations), new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable.
Because none of these criteria apply to your supplemental application, you are exempt from this requirement.
🕺🏻
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Post by sayhey24 on Apr 24, 2018 18:22:18 GMT -5
How often is a Black Box removed from a drug? Usually the drug is rushed to market and after a few years and it making a mess of its users the black box is added. Its interesting that lung function is suppose to diminish more in diabetics but what I am hearing is most afrezza users are not seeing a decrease after three years and some are seeing an increase. I guess the FDA saw this as huge news too. www.diabetes.org/newsroom/press-releases/2008/reduced-lung-capacity.html |
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Post by agedhippie on Apr 24, 2018 18:32:55 GMT -5
Look at the data people. In this case the original REMS letter that they are referencing. This original letter simply said that "The goal of the Afrezza REMS is to mitigate the risk of acute bronchospasm associated with Afrezza by" and then goes on to list four channels of communications and to set a timeline to report progress. Mannkind have asserted that the plan has been executed and the FDA is agreeing and saying do not bother to do then year 7 progress report. The pediatric comment is there because the same drug is being used for adult and pediatric use and so is covered by the original (now complete) REMS.
The label is untouched by this letter.
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Post by akemp3000 on Apr 24, 2018 18:54:17 GMT -5
In the bigger picture, this is excellent news that the FDA now acknowledges the benefits of lung delivery of Afrezza (Technosphere) outweighs many of the now DEAD arguments against it. This is excellent timing prior to the STAT study results being released at the ADA. Previously closed minds are about to be pried opened.
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Post by agedhippie on Apr 24, 2018 19:11:33 GMT -5
In the bigger picture, this is excellent news that the FDA now acknowledges the benefits of lung delivery of Afrezza (Technosphere) outweighs many of the now DEAD arguments against it. This is excellent timing prior to the STAT study results being released at the ADA. Previously closed minds are about to be pried opened. Not what it means at all. This is about risk mitigation, nothing else. |
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Post by akemp3000 on Apr 24, 2018 19:17:17 GMT -5
In the bigger picture, this is excellent news that the FDA now acknowledges the benefits of lung delivery of Afrezza (Technosphere) outweighs many of the now DEAD arguments against it. This is excellent timing prior to the STAT study results being released at the ADA. Previously closed minds are about to be pried opened. Not what it means at all. This is about risk mitigation, nothing else. Prior to the letter, the REMS arguments existed and could be used by competitors against Afrezza. Now they don't. |
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