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Post by olebob1 on Apr 24, 2018 19:19:41 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. Risk mitigation is Good?, Bad?, Huge? Necessary? Breakthrough? Unnecessary? Wonderful? Soon to be forgotten? Buy? Sell? |
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Post by digger on Apr 24, 2018 19:20:16 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. I agree with AH. REMS is just to insure that the general medical community is made aware of the risks of a drug. Once the FDA is happy that has been accomplished, the REMS requirement is removed. It won't have any effect on the label. In fact, I don't recall a company ever issuing a press release to announce it no longer needed to do REMS. It's really not significant news. |
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Post by digger on Apr 24, 2018 19:24:38 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. No, there are no REMS "arguments." REMS is simply about insuring that a drug's risks are distributed throughout the medical community. The REMS instructions are to that effect -- operate a REMS website, mail letters to doctors, hand out literature at meetings, etc. There's nothing there that a competitor could use against Mannkind or afrezza. |
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Post by ashiwi on Apr 24, 2018 19:31:55 GMT -5
Now you know why there was so much short covering this past week,
It’s also why the $2 calls were so active last week,
The “in crowd” knew this news was coming.
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Post by ptass on Apr 24, 2018 19:36:22 GMT -5
Does the communication refer to the warrning or some other type of literature. I'm thinking the warrning label.
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Post by sportsrancho on Apr 24, 2018 19:37:58 GMT -5
SO just made this comment:
I agree that it does not mandate removal of the black box. Ironically, the REMS details pretty much mirror the black box which could lead to an argument of possible change (though the company would likely need to file to remove the box).
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Post by sayhey24 on Apr 24, 2018 19:44:27 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. I am reading NDA 022472 AFREZZA® (insulin human) Inhalation Powder RISK EVALUATION AND MITIGATION STRATEGY (REMS) Most recent modification: 04/2015 www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM403785.pdf It says The FDA has required this safety notice as part of the AFREZZA REMS (Risk Evaluation and Mitigation Strategy) to inform healthcare providers (HCPs) about the following serious risks of AFREZZA: •Risk of Acute Bronchospasm in Patients with Chronic Lung Disease. •Counsel patients to inform their HCP if they have a history of lung disease Do not use in patients with chronic lung disease • Appropriate Patient Selection. AFREZZA is contraindicated in patients with: • Chronic lung disease such as asthma or chronic obstructive pulmonary disease (COPD) • Patient Evaluation Before Initiating Therapy. • Before initiating, prescribers must perform a detailed medical history, physical examination, and spirometry (FEV1) in all patients, to identify potential underlying lung disease If I am reading this correctly it says "as part of the AFREZZA REMS (Risk Evaluation and Mitigation Strategy) Before initiating, prescribers must perform a detailed medical history, physical examination, and spirometry (FEV1) in all patients, to identify potential underlying lung disease If they are really dropping the REMS then is seems the requirement which is part of the REMS for the spirometry is gone too. It would also seem the Safety notice aka "the black box" warning of the risk of Acute Bronchospasm in Patients with Chronic Lung Disease is also gone. |
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Post by digger on Apr 24, 2018 19:48:23 GMT -5
SO just made this comment: I agree that it does not mandate removal of the black box. Ironically, the REMS details pretty much mirror the black box which could lead to an argument of possible change (though the company would likely need to file to remove the box). I disagree. As I indicate in some earlier posts, REMS is basically no more than an information service a company is forced to supply to see to it that risk information gets around the healthcare community in general. The wording is the same because that was the risk information that had to be distributed. But satisfactory accomplishment of the information service function does not provide an argument to change the black box or anything else. At best, it might save Mannkind a little money. |
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Post by digger on Apr 24, 2018 19:52:36 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. I am reading NDA 022472 AFREZZA® (insulin human) Inhalation Powder RISK EVALUATION AND MITIGATION STRATEGY (REMS) Most recent modification: 04/2015 www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM403785.pdf It says The FDA has required this safety notice as part of the AFREZZA REMS (Risk Evaluation and Mitigation Strategy) to inform healthcare providers (HCPs) about the following serious risks of AFREZZA: •Risk of Acute Bronchospasm in Patients with Chronic Lung Disease. •Counsel patients to inform their HCP if they have a history of lung disease Do not use in patients with chronic lung disease • Appropriate Patient Selection. AFREZZA is contraindicated in patients with: • Chronic lung disease such as asthma or chronic obstructive pulmonary disease (COPD) • Patient Evaluation Before Initiating Therapy. • Before initiating, prescribers must perform a detailed medical history, physical examination, and spirometry (FEV1) in all patients, to identify potential underlying lung disease If I am reading this correctly it says "as part of the AFREZZA REMS (Risk Evaluation and Mitigation Strategy) Before initiating, prescribers must perform a detailed medical history, physical examination, and spirometry (FEV1) in all patients, to identify potential underlying lung disease If they are really dropping the REMS then is seems the requirement which is part of the REMS for the spirometry is gone too. It would also seem the Safety notice aka "the black box" warning of the risk of Acute Bronchospasm in Patients with Chronic Lung Disease is also gone. I'm quite positive you aren't reading it correctly -- see my last few posts. Google REMS and study what it is meant to accomplish. All that's changing is that MNKD will no longer need to conduct the "communication plan" as originally dictated by the FDA. |
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Post by agedhippie on Apr 24, 2018 19:59:46 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. I am reading NDA 022472 AFREZZA® (insulin human) Inhalation Powder RISK EVALUATION AND MITIGATION STRATEGY (REMS) Most recent modification: 04/2015 www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM403785.pdf It says The FDA has required this safety notice as part of the AFREZZA REMS (Risk Evaluation and Mitigation Strategy) to inform healthcare providers (HCPs) about the following serious risks of AFREZZA: •Risk of Acute Bronchospasm in Patients with Chronic Lung Disease. •Counsel patients to inform their HCP if they have a history of lung disease Do not use in patients with chronic lung disease • Appropriate Patient Selection. AFREZZA is contraindicated in patients with: • Chronic lung disease such as asthma or chronic obstructive pulmonary disease (COPD) • Patient Evaluation Before Initiating Therapy. • Before initiating, prescribers must perform a detailed medical history, physical examination, and spirometry (FEV1) in all patients, to identify potential underlying lung disease If I am reading this correctly it says "as part of the AFREZZA REMS (Risk Evaluation and Mitigation Strategy) Before initiating, prescribers must perform a detailed medical history, physical examination, and spirometry (FEV1) in all patients, to identify potential underlying lung disease If they are really dropping the REMS then is seems the requirement which is part of the REMS for the spirometry is gone too. It would also seem the Safety notice aka "the black box" warning of the risk of Acute Bronchospasm in Patients with Chronic Lung Disease is also gone. It's not that you are not reading it correctly, it's that you are misunderstanding the purpose of REMS. They are to ensure that everyone is aware of this data to which end the REMS is a communications plan. Once the communications plans is complete so is the REMS. In this case Mannkind is saying, and the FDA is accepting, that all doctors have been told of the requirement to perform that test so the REMS has done it's task. It does not mean that they can ignore the test. In fact now the REMS is complete doctors can be sued for not applying the test if there are complications since that is negligence. |
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Post by letitride on Apr 24, 2018 20:03:20 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. I am reading NDA 022472 AFREZZA® (insulin human) Inhalation Powder RISK EVALUATION AND MITIGATION STRATEGY (REMS) Most recent modification: 04/2015 www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM403785.pdf It says The FDA has required this safety notice as part of the AFREZZA REMS (Risk Evaluation and Mitigation Strategy) to inform healthcare providers (HCPs) about the following serious risks of AFREZZA: •Risk of Acute Bronchospasm in Patients with Chronic Lung Disease. •Counsel patients to inform their HCP if they have a history of lung disease Do not use in patients with chronic lung disease • Appropriate Patient Selection. AFREZZA is contraindicated in patients with: • Chronic lung disease such as asthma or chronic obstructive pulmonary disease (COPD) • Patient Evaluation Before Initiating Therapy. • Before initiating, prescribers must perform a detailed medical history, physical examination, and spirometry (FEV1) in all patients, to identify potential underlying lung disease If I am reading this correctly it says "as part of the AFREZZA REMS (Risk Evaluation and Mitigation Strategy) Before initiating, prescribers must perform a detailed medical history, physical examination, and spirometry (FEV1) in all patients, to identify potential underlying lung disease If they are really dropping the REMS then is seems the requirement which is part of the REMS for the spirometry is gone too. It would also seem the Safety notice aka "the black box" warning of the risk of Acute Bronchospasm in Patients with Chronic Lung Disease is also gone. Only the share price will know for sure! |
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Post by digger on Apr 24, 2018 20:12:03 GMT -5
One thing that REMS might be able to assess is the risk of hypoglycemia. I'd presume that data was likely collected on that issue. It would be interesting to find out whether enough data was collected to judge the risk of afrezza versus humalog and novolog.
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Post by robbmo on Apr 24, 2018 20:18:44 GMT -5
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Post by peppy on Apr 24, 2018 20:23:47 GMT -5
we were able to determine, the letter means MNKD no longer had to run this website. www.afrezzarems.com |
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Post by compound26 on Apr 24, 2018 20:36:38 GMT -5
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