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Post by prcgorman2 on May 2, 2018 13:31:58 GMT -5
The GlobeNewswire article said, "The REMS consisted of a communication plan intended to inform prescribers of Afrezza of the potential risks associated with the use of Afrezza as described in the boxed warning."
So what is the real impact here? I assume the black box stays in place, but now Mannkind doesn't have to inform prescribers? Is that it?
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Post by goyocafe on May 2, 2018 13:39:27 GMT -5
The GlobeNewswire article said, "The REMS consisted of a communication plan intended to inform prescribers of Afrezza of the potential risks associated with the use of Afrezza as described in the boxed warning." So what is the real impact here? I assume the black box stays in place, but now Mannkind doesn't have to inform prescribers? Is that it? They seem to be able to post on social media with fewer warnings to start. |
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Post by digger on May 2, 2018 13:57:05 GMT -5
The GlobeNewswire article said, "The REMS consisted of a communication plan intended to inform prescribers of Afrezza of the potential risks associated with the use of Afrezza as described in the boxed warning." So what is the real impact here? I assume the black box stays in place, but now Mannkind doesn't have to inform prescribers? Is that it? This was thoroughly discussed in mnkd.proboards.com/thread/9858/determines-afrezza-rems-communication-plan Although some some to think it means something, all it really means is exactly what it says: "we have determined that the communication plan is no longer necessary as an element of the REMS..." and this was the communication plan: 1. REMS letters -- "MannKind Corporation will send a REMS Letter for Healthcare Providers and REMS Letter for Professional Societies within 60 days of this REMS approval (June 2014) and again after one year from the date of the REMS approval. " 2. A REMS fact sheet that was to be distributed to healthcare providers for 12 months after the approval. 3. A REMS website 4. Dissemination of REMS information at scientific meetings Mannkind was also supposed to submit REMS assessments at 18 monthss, 3 years, and 7 years after the initial REMS approval. And all of that no longer needs to be done. As of 12 months after approval of the original REMS plan, no one was required to inform prescribers about anything. There is no change in the black box, warnings, or anything else on the label. |
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Post by Omega on May 2, 2018 14:08:41 GMT -5
Blackbox still currently in place, But this is a step in the right direction to remove it. AFREZZA's RISK EVALUATION AND MITIGATION STRATEGY (REMS): www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM403785.pdfGOAL The goal of the Afrezza REMS is to mitigate the risk of acute bronchospasm associated with Afrezza by: • Informing healthcare providers that there is risk of acute bronchospasm associated with AFREZZA in patients with chronic lung disease • Informing healthcare providers that acute bronchospasm has been observed with AFREZZA in patients with asthma and COPD • Informing healthcare providers that AFREZZA is contraindicated in patients with chronic lung disease • Informing healthcare providers of the need to evaluate patients for lung disease before starting on AFREZZA |
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Post by prcgorman2 on May 2, 2018 14:29:31 GMT -5
Excellent feedback. Thank you all.
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Post by digger on May 2, 2018 14:38:27 GMT -5
Blackbox still currently in place, But this is a step in the right direction to remove it. AFREZZA's RISK EVALUATION AND MITIGATION STRATEGY (REMS): www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM403785.pdfGOAL The goal of the Afrezza REMS is to mitigate the risk of acute bronchospasm associated with Afrezza by: • Informing healthcare providers that there is risk of acute bronchospasm associated with AFREZZA in patients with chronic lung disease • Informing healthcare providers that acute bronchospasm has been observed with AFREZZA in patients with asthma and COPD • Informing healthcare providers that AFREZZA is contraindicated in patients with chronic lung disease • Informing healthcare providers of the need to evaluate patients for lung disease before starting on AFREZZA Sorry but I have to disagree about it being a "step in the right direction to remove it." It's not a step in either the right direction or the wrong direction. It has nothing to do with with changing the label one way or another. And if you just think about it, removing the black box is impossible because of the simple fact that during the trials, patients with COPD experienced some sort of bronchospasm serious enough to merit the black box. Unless MNKD comes up with a solution to that issue, the black box must stay. |
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Post by brotherm1 on May 2, 2018 14:55:20 GMT -5
Blackbox still currently in place, But this is a step in the right direction to remove it. AFREZZA's RISK EVALUATION AND MITIGATION STRATEGY (REMS): www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM403785.pdfGOAL The goal of the Afrezza REMS is to mitigate the risk of acute bronchospasm associated with Afrezza by: • Informing healthcare providers that there is risk of acute bronchospasm associated with AFREZZA in patients with chronic lung disease • Informing healthcare providers that acute bronchospasm has been observed with AFREZZA in patients with asthma and COPD • Informing healthcare providers that AFREZZA is contraindicated in patients with chronic lung disease • Informing healthcare providers of the need to evaluate patients for lung disease before starting on AFREZZA Sorry but I have to disagree about it being a "step in the right direction to remove it." It's not a step in either the right direction or the wrong direction. It has nothing to do with with changing the label one way or another. And if you just think about it, removing the black box is impossible because of the simple fact that during the trials, patients with COPD experienced some sort of bronchospasm serious enough to merit the black box. Unless MNKD comes up with a solution to that issue, the black box must stay. “Impossible”? That means they absolutely cannot have it removed. Pretty strong wording there digger. I’m curious to know what is your background, education and experience pertaining to FDA regulations? |
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Post by mnholdem on May 2, 2018 15:13:30 GMT -5
Even if the black box is retained the mandatory requirement for a FEV1 test of every patient can certainly be removed.
For example, Afrezza is not recommended for women who are pregnant. Why not throw in a mandatory pregnancy test into the black box?
The FEV1 is an unnecessary "what-if" that a narrow-minded (or corrupt) FDA attached to the black box. Even Exubera didn't have it, and that inhaled insulin powder was far more dangerous than inert Technosphere particles.
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Post by digger on May 2, 2018 16:48:43 GMT -5
Even if the black box is retained the mandatory requirement for a FEV1 test of every patient can certainly be removed. For example, Afrezza is not recommended for women who are pregnant. Why not throw in a mandatory pregnancy test into the black box? The FEV1 is an unnecessary "what-if" that a narrow-minded (or corrupt) FDA attached to the black box. Even Exubera didn't have it, and that inhaled insulin powder was far more dangerous than inert Technosphere particles. No, I disagree. The box specifically instructs the doctor -- "Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients." I think the key words there are "to identify potential lung disease." Pulmonary function tests are simply a necessary component of identifying potential lung disease. Even though it's not a requirement, I suspect a chest xray would be required as well. Exubera's insert had this: "Because of the effect of EXUBERA on pulmonary function, all patients should have pulmonary function assessed prior to initiating therapy with EXUBERA (see PRECAUTIONS : Pulmonary Function). The use of EXUBERA in patients with underlying lung disease, such as asthma or COPD, is not recommended because the safety and efficacy of EXUBERA in this population have not been established (see PRECAUTIONS: Underlying Lung Disease)." Again, stating that pulmonary function should be assessed implies that pulmonary function tests are required. Like I said, the box is there because during the trials, some patients with COPD evidently experienced bronchospasm severe enough to require ruling out lung disease in future patients. I don't see how that could possibly be changed. How else would you determine whether someone might be at risk for a severe reaction? Specific to FEV1, another secondary goal is to assess long term effects on lung function. Afrezza demonstrated a negative effect on FEV1. Short term the effect appears reversible. But what about long term? You have to do something to insure that there won't be some long term ill effect. |
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Post by digger on May 2, 2018 16:57:48 GMT -5
Sorry but I have to disagree about it being a "step in the right direction to remove it." It's not a step in either the right direction or the wrong direction. It has nothing to do with with changing the label one way or another. And if you just think about it, removing the black box is impossible because of the simple fact that during the trials, patients with COPD experienced some sort of bronchospasm serious enough to merit the black box. Unless MNKD comes up with a solution to that issue, the black box must stay. “Impossible”? That means they absolutely cannot have it removed. Pretty strong wording there digger. I’m curious to know what is your background, education and experience pertaining to FDA regulations? See my previous comment. To me, this is a simple exercise in logic. The trials showed people with lung disease were at risk for developing bronchospasms that were severe enough to merit the black box. In other words, the trials have proven that this group of patients is at risk. What choice is there but to assess afrezza potential patients to determine whether they too might have lung disease sufficient to put them at risk for severe bronchospams? |
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Post by Omega on May 2, 2018 17:09:50 GMT -5
Black Boxes can be removed by the FDA, they can look at data from the post-market studies and adjust regulatory actions based on additional information.
I've found nothing that says a black box is written in stone.
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Post by digger on May 2, 2018 17:16:38 GMT -5
Black Boxes can be removed by the FDA, they can look at data from the post-market studies and adjust regulatory actions based on additional information. I've found nothing that says a black box is written in stone. What's "written in stone" is that COPD patients are at risk of severe bronchospasm if they use afrezza. Apparently, the FDA felt the effects were severe enough to motivate the black box requirement. What "post-market studies" could you do to reverse what has already been demonstrated? If everyone that has evidence of lung disease is being excluded from using afrezza, where will you get any "additional information"? |
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Post by mnholdem on May 2, 2018 17:17:07 GMT -5
Even if the black box is retained the mandatory requirement for a FEV1 test of every patient can certainly be removed. For example, Afrezza is not recommended for women who are pregnant. Why not throw in a mandatory pregnancy test into the black box? The FEV1 is an unnecessary "what-if" that a narrow-minded (or corrupt) FDA attached to the black box. Even Exubera didn't have it, and that inhaled insulin powder was far more dangerous than inert Technosphere particles. No, I disagree. The box specifically instructs the doctor -- " Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients."I think the key words there are "to identify potential lung disease." Pulmonary function tests are simply a necessary component of identifying potential lung disease. Even though it's not a requirement, I suspect a chest xray would be required as well. Exubera's insert had this: "Because of the effect of EXUBERA on pulmonary function, all patients should have pulmonary function assessed prior to initiating therapy with EXUBERA (see PRECAUTIONS : Pulmonary Function). The use of EXUBERA in patients with underlying lung disease, such as asthma or COPD, is not recommended because the safety and efficacy of EXUBERA in this population have not been established (see PRECAUTIONS: Underlying Lung Disease)." Again, stating that pulmonary function should be assessed implies that pulmonary function tests are required. Like I said, the box is there because during the trials, some patients with COPD evidently experienced bronchospasm severe enough to require ruling out lung disease in future patients. I don't see how that could possibly be changed. How else would you determine whether someone might be at risk for a severe reaction? Of course you do, because you miss the point. There is a huge difference between "not recommending" - without a black box warning, I might add - and instructions within a black box to perform a FEV1 test to "identify potential lung disease..." Potential? If the doctor reviews the patient's detailed medical history, and thus know that an otherwise healthy (except for diabetes) patient does not have asthma/COPD, why be forced perform a FEV1 anyway? The black box requirement that ALL patients be tested regardless of medical history is ridiculous, redundant and the FDA's head review physician decided to add it after the ADCOM voted AGAINST him and unanimously recommended approval for Afrezza. I don't if you've read the transcripts of that hearing, but the FDA's lead physician took a LOT of crap from the ADCOM doctors for other unexplainable actions he took, which I have posted verbatim on ProBoards over the past few years. Whether on his own or under directions of his superior (remember Margaret?) the FDA's lead physician seemed bent on stopping Afrezza from being approved. |
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Post by digger on May 2, 2018 17:28:36 GMT -5
No, I disagree. The box specifically instructs the doctor -- "Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients."I think the key words there are "to identify potential lung disease." Pulmonary function tests are simply a necessary component of identifying potential lung disease. Even though it's not a requirement, I suspect a chest xray would be required as well. Exubera's insert had this: "Because of the effect of EXUBERA on pulmonary function, all patients should have pulmonary function assessed prior to initiating therapy with EXUBERA (see PRECAUTIONS : Pulmonary Function). The use of EXUBERA in patients with underlying lung disease, such as asthma or COPD, is not recommended because the safety and efficacy of EXUBERA in this population have not been established (see PRECAUTIONS: Underlying Lung Disease)." Again, stating that pulmonary function should be assessed implies that pulmonary function tests are required. Like I said, the box is there because during the trials, some patients with COPD evidently experienced bronchospasm severe enough to require ruling out lung disease in future patients. I don't see how that could possibly be changed. How else would you determine whether someone might be at risk for a severe reaction? Of course you do, because you miss the point. There is a huge difference between "not recommending" - which was without a black box warning, I might add - and instructions within a black box to perform a FEV1 test to "identify potential lung disease..." Potential?bIf the doctor reviews the patient's detailed medical history, s/he would then already know that the patient has asthma/COPD but must perform a FEV1 anyway. The black box requirement that ALL patients be tested regardless of medical history is ridiculous, redundant and the FDA's head review physician decided to add it after the ADCOM voted unanimously AGAINST him And recommended approving Afrezza. The FDA's lead physician took a lot of crap from the ADCOM doctors at that hearing for other unexplainable actions he took, which I have posted verbatim on ProBoards over the past few years. Evidently, the effects seen with exubera were not severe enough to warrant a black while those of afrezza were. A doctor does not routinely screen patients for lung disease unless they have complaints related to possible lung disease, so simply reviewing the medical history is insufficient. Whether it's ridiculous or not may be debatable, but the simple fact is that it has been imposed based on the trial data and with a specific purpose. I can think of no way of ever removing it as long as the trial data exists. Plus, it makes sense. Suppose you were the doctor and were contemplating starting someone on afrezza. Given afrezza's history of bronchospasm in COPD patients, wouldn't you want to rule out the possibility of lung disease in the patient before starting them on afrezza? It would be a little embarrassing to have a patient kneel over dead from a reaction that you might have prevented. |
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Post by mnholdem on May 2, 2018 17:33:22 GMT -5
Your first sentence is blatantly untrue! Be careful not to make those kind of erroneous statements if you don't know trial history. This is not Yahoo or StockTwits.
Incidentally, the trial data does NOT support it. The ADCOM physicians all agreed that the incidence were so few as to render them not statistically significant. Caution was suggested with patients with COPD, but not a mandated lung test on all patients before prescribing. That was entirely a renegade final action by the FDA.
When they couldn't stop it's approval, they added a barrier that would make Afrezza much more difficult to prescribe, IMO. This was at the time when the FDA Commissioner's husband, a hedge fund manager, had MNKD holdings. Those fund records have also been posted on ProBoard.
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