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Post by bill on Apr 25, 2018 7:54:32 GMT -5
I've learned that when agedhippie and matt agree, they are almost always correct. The news is good but not huge. Spirometry remains. Black box remains. While I agree with your assessment, there will be more certainty and additional clarification from MNKD, as to their interpretation. I hope they give us more color on their direction from this point, i.e.; modifications to the label, etc. in today's PR. FWIW, as I posted on the related thread, the revised Afrezza site no longer has a black box warning, but the site still does refer to the spirometry test. |
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Post by hellodolly on Apr 25, 2018 7:58:59 GMT -5
While I agree with your assessment, there will be more certainty and additional clarification from MNKD, as to their interpretation. I hope they give us more color on their direction from this point, i.e.; modifications to the label, etc. in today's PR. @agedhippe matt FWIW, as I posted on the related thread, the revised Afrezza site no longer has a black box warning, but the site still does refer to the spirometry test. TY |
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Post by myocat on Apr 25, 2018 8:12:38 GMT -5
Just don't f*&(king dilute to halt the PPS momentum like they did this past monts, year.
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Post by sportsrancho on Apr 25, 2018 8:13:55 GMT -5
A comment from SO,
• Removal of REMS provides some value to the Technosphere platform. Technosphere is the carrier particle that encapsulates the desired drug. Technosphere combined with human insulin creates Afrezza. Technosphere combined with Treprostinil would create what we call TepT. Technosphere just cleared a hurdle on its safety profile with the release of REMS. This makes it more salable to potential partners to use the technology with other drugs. The value of Technosphere can be debated, but there is no denying that this REMS news would increase the value of the technology. Technosphere has its detractors that feel it has little value, and its supporters that feel it is very valuable. To date, only 1 deal has been struck with Receptor Life Sciences. That deal delivered very minimal upfront cash, and Receptor has yet to get very far in progressing its drug.
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Post by barnstormer on Apr 25, 2018 8:17:10 GMT -5
The FDA letter was probably expected and may be why they haven't finalized the deal Mike said they have a term sheet from. This helps sweeten the deal for MNKD.
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Post by agedhippie on Apr 25, 2018 8:45:36 GMT -5
While I agree with your assessment, there will be more certainty and additional clarification from MNKD, as to their interpretation. I hope they give us more color on their direction from this point, i.e.; modifications to the label, etc. in today's PR. FWIW, as I posted on the related thread, the revised Afrezza site no longer has a black box warning, but the site still does refer to the spirometry test. The warning at the bottom (bold section is as highlighted on the website and is a paraphrase of the black box warning) - 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.Mannkind have done a better job on the web site this time and buried the black box warning in the general warning. This is what the big drug companies do (take a look at Trulicity) and the FDA seems to permit it provided the black box warning is highlighted. |
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Post by digger on Apr 25, 2018 9:13:44 GMT -5
Since the FDA has informed MannKind that a REMS is no longer required for Afrezza, then that means the following are no longer required and are not an issue: 1. Informing healthcare providers that there is risk of acute bronchospasm associated with AFREZZA in patients with chronic lung disease. 2. Informing healthcare providers that acute bronchospasm has been observed with AFREZZA in patients with asthma and COPD. 3. Informing healthcare providers that AFREZZA is contraindicated in patients with chronic lung disease. 4. Informing healthcare providers of the need to evaluate patients for lung disease before starting on AFREZZA. The REMS is a program required by the FDA to manage known and/or potential serious risk(s) associated with a product. The FDA has determined that any and all risks associated with Afrezza described and detailed in the REMS is no longer seen as a potential health risk, hence, the REMS is no longer required. Put simply, the benefit outweighs the risk and the FDA is no longer requiring a REMS and Afrezza is no longer associated with the risks described in the REMS and is unchained from any and all details described in the REMS. If you will take note and notice number 4 there as a goal of the REMS, or should I say, plan of action, it is referring to the spirometry. FEV1 and Black Box will be gone. No, all it means is that Mannkind no longer has to take the steps listed in the original REMS document -- www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2016-04-01_REMS_document.pdf -- to execute the "communication plan" that was devised to inform healthcare providers of all those risks. |
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Post by od on Apr 25, 2018 9:29:40 GMT -5
It seems to me that the consensus of the most reasonable/least magical thinking posters is that the letter confirming that MNKD has satisfied REMS requirements, while a good thing, has nothing to do with the labels boxed warning. We can beat up on this forever, but the way to overcome provider's concerns about the boxed warning is personal experience prescribing Afrezza (or any product with a boxed warning). Re: labeling change, has MNKD made a formal sNDA request for the boxed warning repeal? We know it is a goal, but has the process started?
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Post by mango on Apr 25, 2018 9:31:35 GMT -5
Since the FDA has informed MannKind that a REMS is no longer required for Afrezza, then that means the following are no longer required and are not an issue: 1. Informing healthcare providers that there is risk of acute bronchospasm associated with AFREZZA in patients with chronic lung disease. 2. Informing healthcare providers that acute bronchospasm has been observed with AFREZZA in patients with asthma and COPD. 3. Informing healthcare providers that AFREZZA is contraindicated in patients with chronic lung disease. 4. Informing healthcare providers of the need to evaluate patients for lung disease before starting on AFREZZA. The REMS is a program required by the FDA to manage known and/or potential serious risk(s) associated with a product. The FDA has determined that any and all risks associated with Afrezza described and detailed in the REMS is no longer seen as a potential health risk, hence, the REMS is no longer required. Put simply, the benefit outweighs the risk and the FDA is no longer requiring a REMS and Afrezza is no longer associated with the risks described in the REMS and is unchained from any and all details described in the REMS. If you will take note and notice number 4 there as a goal of the REMS, or should I say, plan of action, it is referring to the spirometry. FEV1 and Black Box will be gone. No, all it means is that Mannkind no longer has to take the steps listed in the original REMS document -- www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2016-04-01_REMS_document.pdf -- to execute the "communication plan" that was devised to inform healthcare providers of all those risks. "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." I have the FDA Adverse Events report right here and it shows that the potential risks are not risks at all and the benefits of Afrezza outweights the potential risks described in the REMS (that no longer exists). |
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Post by ilovekauai on Apr 25, 2018 9:33:54 GMT -5
So far we've gotten a four cent bump out of this earth shattering "news," that is really much ado about nothing. We're still under lock & key with labeling. Nothing has really changed outside an FDA letter.
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Post by Deleted on Apr 25, 2018 9:42:43 GMT -5
So far we've gotten a four cent bump out of this earth shattering "news," that is really much ado about nothing. We're still under lock & key with labeling. Nothing has really changed outside an FDA letter. Markets ultimately respond to growth in revenue, profit and cash flow. This good news helps but its not the holy grail. Let's see what else happens over the next 4-6 months. |
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Post by mnholdem on Apr 25, 2018 9:50:16 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.
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Post by agedhippie on Apr 25, 2018 9:59:45 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.
I think that is possible (even likely), but it is going to be on the far side of the lung trial mandated by the approval. |
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Post by digger on Apr 25, 2018 10:11:06 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." |
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Post by celo on Apr 25, 2018 10:23:11 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?
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