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Post by mango on Apr 25, 2018 10:37:28 GMT -5
There was a situation a few years ago where an inhaled medication was approved for label change followed a REMS change.
The FDA approved an sNDA for label changes to ADASUVE (loxapine) inhalation powder for the acute treatment of agitation associated with bipolar I or schizophrenia in adult patients.
The approved label changes included the removal of the requirement for immediate onsite access to equipment and personnel trained to manage acute bronchospasm, including advanced airway management. This came after the company consulted the FDA on the Risk Evaluation Mitigation Strategy (REMS) of the drug, including the impact of certain requirements in the previous REMS. The labeling changes consisted of revisions to the Boxed Warning and Warning and Precautions sections of the Prescribing Information.
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I could see something similar happening with Afrezza, where it remains contraindicated for patients with chronic lung disease, such as asthma or chronic obstructive pulmonary disease (COPD), because of the risk of acute bronchospasm. However the current requirement that EVERY patient be given a FEV1 test, even if s/he does not have a chronic lung disease, could be removed. In place of this current requirement the label would recommend periodic lung tests but not mandate them.
It's possible that MannKind's CMO Dr. David Kendall is consulting with the FDA and the company is working toward submitting and getting approval of a new sNDA.
 The problem is knowing whether someone has lung disease to begin with and doesn't know it. That's why they have that line about "detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients." If someone has asthma they will know it long before having a simple bedside spiro done prior to an eval for an Afrezza prescription. Since all subcutaneous insulins are amyloidogenic should there not be a mandated REMS to alert healthcare providers of this potential risk, and should there not be mandatory periodic physical screenings for lumps, masses, and/or nodules of all patients prescribed SC insulin? I think so (LIDA is substantially more prevalent world-wide than potential acute bronchospasm from Afrezza usage), which is why mango here has been exchanging emails with FDA for some time now and initiated an investigation and is also preparing a Citizens Petition. |
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Post by digger on Apr 25, 2018 10:38:30 GMT -5
Removing the REMS may also allow Mannkind to advertise without the massively long warning at the end of their television adds. The REMS might of put a cap on what Mannkind could say or how they could say it. Now that doctors and providers have all received the necessary education on the risks involved with prescribing Afrezza, Mannkind possibly can have a much more aggressive and positive ad campaign. Is the new website the first sign of that, with patient experiences and a smaller black box warning label on the bottom? No, plenty of drugs have cleared REMS and they all still have the same long warnings at the end of TV and magazine ads. |
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Post by drman7 on Apr 25, 2018 10:45:40 GMT -5
Removing the REMS may also allow Mannkind to advertise without the massively long warning at the end of their television adds. The REMS might of put a cap on what Mannkind could say or how they could say it. Now that doctors and providers have all received the necessary education on the risks involved with prescribing Afrezza, Mannkind possibly can have a much more aggressive and positive ad campaign. Is the new website the first sign of that, with patient experiences and a smaller black box warning label on the bottom? No, plenty of drugs have cleared REMS and they all still have the same long warnings at the end of TV and magazine ads. If that's the case, can you name any drugs that are inhaled that have cleared REMS and still have the same long warnings....... |
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Post by dreamboatcruise on Apr 25, 2018 11:14:46 GMT -5
Wow, I missed a lot of sound and fury this morning. When I read the news I nearly had a bronchospasm  |
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Post by agedhippie on Apr 25, 2018 11:59:17 GMT -5
No, plenty of drugs have cleared REMS and they all still have the same long warnings at the end of TV and magazine ads. If that's the case, can you name any drugs that are inhaled that have cleared REMS and still have the same long warnings....... Advair, probably a ton more but that was one that sprang immediately to mind. |
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Post by drman7 on Apr 25, 2018 12:03:50 GMT -5
If that's the case, can you name any drugs that are inhaled that have cleared REMS and still have the same long warnings....... Advair, probably a ton more but that was one that sprang immediately to mind. Didn't the FDA removed the black box warning on Advair last year? |
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Post by agedhippie on Apr 25, 2018 12:04:37 GMT -5
Removing the REMS may also allow Mannkind to advertise without the massively long warning at the end of their television adds. The REMS might of put a cap on what Mannkind could say or how they could say it. Now that doctors and providers have all received the necessary education on the risks involved with prescribing Afrezza, Mannkind possibly can have a much more aggressive and positive ad campaign. Is the new website the first sign of that, with patient experiences and a smaller black box warning label on the bottom?That's just decent web design. Look at Trulicity as an example and compare it to the Advair site. I don't know who designed the Advair site but they should be shot. |
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Post by mango on Apr 25, 2018 13:46:20 GMT -5
Advair, probably a ton more but that was one that sprang immediately to mind. Didn't the FDA removed the black box warning on Advair last year? FDA removed the Black Box Warnings this past December on more than just Advair it was all medications that contain long-acting beta agonists in combination with inhaled corticosteroids—For example, Breo, Dulera, Airduo, and Symbicort |
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Post by mango on Apr 25, 2018 14:19:11 GMT -5
REMS ReportsREMS countCurrently, there are 74 REMS. • 45 [61%] include "elements to assure safe use' (ETASU). REMS with ETASU typically require clinicians or health care settings to become certified prior to prescribing and to participate in additional REMS activities, such as training, patient counseling, and monitoring. • 11 [15%] include only a "communication plan" REMS element which is informational in nature. These communication plans are typically composed of letters, websites, and fact sheets describing the specific safety risks identified in the REMS. • 18 [24%] include only the "medication guide" REMS element. Even products that do not have "medication guide" REMS elements may have medication guides as part of their labeling. www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsData.page
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Post by agedhippie on Apr 25, 2018 14:57:37 GMT -5
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. Just because the REMS communication plan is complete does not mean the black box warning for bronchial spasms (which is what the REMS plan was for) goes away. Competitors can still use it against Afrezza as long as it is on the label. |
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Post by mytakeonit on Apr 25, 2018 16:00:26 GMT -5
The key here is that the endos will see and understand the REMS.
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Post by agedhippie on Apr 25, 2018 17:41:53 GMT -5
The key here is that the endos will see and understand the REMS. Actually the key here is that the endos have seen and understood the REMS or Mannkind would have to continue with it. Right idea, wrong tense  |
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Post by mytakeonit on Apr 25, 2018 18:56:50 GMT -5
Hmmm ... since they say ... what is Afrezza? Oh, the new thing that gives you lung issues, etc, etc. FDA signed yesterday that say we don't need the REMS anymore. Interesting ...
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Post by sayhey24 on Apr 25, 2018 19:38:16 GMT -5
Prior to the letter, the REMS arguments existed and could be used by competitors against Afrezza. Now they don't. Just because the REMS communication plan is complete does not mean the black box warning for bronchial spasms (which is what the REMS plan was for) goes away. Competitors can still use it against Afrezza as long as it is on the label. Its not the communication plan which is complete, it is the REMS. The communication plan was the vehicle for communicating the risks of afrezza and has met its goals. The FDA has decided that a REMS is no longer required for Afrezza, i.e. "complete". From the press release - "The Food and Drug Administration (FDA) has completed its review of a supplemental New Drug Application (sNDA) for Afrezza (insulin human) inhalation powder and has determined that the Risk Evaluation and Mitigation Strategy (REMS) communication plan regarding the risks of Afrezza has been completed and has met its goals. As a result, the FDA has decided that a REMS is no longer required for Afrezza." How did this happen? MNKD submitted an sNDA and the sNDA was approved. I suspect the next step is the negotiation of the new label now that the sNDA is approved. Two key points of the REMS was the spirometry testing and notification of bronchial spasms. While I expect the spirometry will be suggested in the future it will no longer be required. I also expect the bronchial spasms warning to stay on the label just not in the black box. Who knows, maybe we will hear what the new label is by ADA2018. As far as competitors using bronchial spasms against afrezza, how many people is this really effecting? I would guess not many. If thats the best the competitors have to compete on, that IMO sounds like great news for afrezza. |
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Post by sayhey24 on Apr 25, 2018 19:43:59 GMT -5
My question for Dr. Kendall would be what data was submitted with the sNDA that allowed the FDA to make the decision a REMS is no longer required? Was it from the 60+ lost studies or clinical results over the last 3 years or both?
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