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Post by peppy on Apr 24, 2018 15:53:03 GMT -5
RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS Section 505-1 of the FDCA authorizes FDA to require the submission of a risk evaluation and mitigation strategy (REMS), if FDA determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks [section 505-1(a)]. In accordance with section 505-1 of FDCA, we have determined that a REMS is necessary for Afrezza (insulin human) Inhalation Powder to ensure the benefits of the drug outweigh the risk of acute bronchospasm in patients with chronic lung disease. We have also determined that a communication plan is necessary to support implementation of the REMS. Your proposed REMS, submitted on June 20, 2014, and appended to this letter, is approved. The REMS consists of a communication plan and a timetable for submission of assessments of the REMS. www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022472Orig1s000ltr.pdfpage 5 In looking at it, I believe the spirometry requirement might go away as the lung testing is part of the REMS... Your REMS must be fully operational before you introduce Afrezza (insulin human) Inhalation Powder into interstate commerce. The REMS assessment plan should include, but is not limited to, the following: 1. REMS communication plan activities: a. Number of healthcare providers and professional societies targeted by the REMS. b. Number of REMS letters sent to healthcare providers and professional societies via email, standard mail, and facsimile, and the dates the letters were sent. Include the number of letters sent via email because the mailed letter was undeliverable. For letters sent via email, include the number of letters successfully delivered, and the number of email letters opened by the recipients. c. Number of REMS Factsheets distributed to healthcare providers by sales representatives and medical liaisons during the reporting period. d. Date the REMS website went live and number of total and unique site visits during the assessment period. e. Names and dates of all scientific meetings during which REMS materials (REMS letters, REMS Factsheet) were distributed 2. Evaluation of healthcare providers’ understanding of: a. The risk of acute bronchospasm associated with Afrezza in patients with chronic lung disease b. Acute bronchospasm has been observed in patients with asthma and COPD using Afrezza c. Afrezza is contraindicated in patients with chronic lung disease d. HCPs should evaluate all patients for lung disease (a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease) before starting on Afrezza 3. Afrezza utilization information including, but not limited to, indication for use and type of prescriber (i.e., endocrinologist, general practitioner, internist, etc.) 4. Safety surveillance: a. Analysis of serious postmarketing case reports of bronchospasm received during the reporting period. Include in the analysis information on whether or not the patient was evaluated for lung disease before receiving Afrezza, and how the patient was evaluated for chronic lung disease (e.g., baseline FEV1, past medical history, physical examination) b. Analysis of postmarketing case reports of serious respiratory adverse events reported for patients with chronic lung disease during the reporting period.
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Post by centralcoastinvestor on Apr 24, 2018 15:53:43 GMT -5
It would be nice to have a press release from MNKD on this subject. They are probably working on it. They may be getting further clarification on what it means. Some have surmised that the spirometry test may be dropped.
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Post by mnkdfann on Apr 24, 2018 15:54:56 GMT -5
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Post by peppy on Apr 24, 2018 15:55:38 GMT -5
It would be nice to have a press release from MNKD on this subject. They are probably working on it. They may be getting further clarification on what it means. Some have surmised that the spirometry test may be dropped. Another question for the shareholders meeting. I think I am so funny.
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Post by goyocafe on Apr 24, 2018 15:56:12 GMT -5
RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS Section 505-1 of the FDCA authorizes FDA to require the submission of a risk evaluation and mitigation strategy (REMS), if FDA determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks [section 505-1(a)]. In accordance with section 505-1 of FDCA, we have determined that a REMS is necessary for Afrezza (insulin human) Inhalation Powder to ensure the benefits of the drug outweigh the risk of acute bronchospasm in patients with chronic lung disease. We have also determined that a communication plan is necessary to support implementation of the REMS. Your proposed REMS, submitted on June 20, 2014, and appended to this letter, is approved. The REMS consists of a communication plan and a timetable for submission of assessments of the REMS. www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022472Orig1s000ltr.pdfpage 5 In looking at it, I believe the spirometry requirement might go away as the lung testing is part of the REMS... Then how about the black box warning, too?
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Post by boca1girl on Apr 24, 2018 15:56:30 GMT -5
It would be nice to have a press release from MNKD on this subject. They are probably working on it. They may be getting further clarification on what it means. Some have surmised that the spirometry test may be dropped. Would this allow us to cancel the long term safety study?
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Post by peppy on Apr 24, 2018 15:56:33 GMT -5
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Post by mnholdem on Apr 24, 2018 16:04:41 GMT -5
This is a very nice find. Thank you!
I wonder if this will have an impact on Afrezza's Boxed WARNING.
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Post by robbmo on Apr 24, 2018 16:04:46 GMT -5
I think it might be even better/huger (if that's a word):
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 peppy on Apr 24, 2018 16:07:27 GMT -5
I think it might be even better/huger (if that's a word):
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. this would be holy chit.
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Post by tingtongtung on Apr 24, 2018 16:08:04 GMT -5
I think it might be even better/huger (if that's a word):
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. That's what I thought too.. Will it speed up pediatric segment massively? That would be huge!
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Post by celo on Apr 24, 2018 16:08:21 GMT -5
Listen all you idiotic health care providers!!! Afrezza is the SAFEST and greatest thing out there. Make it available like it should be!!!!!!!! You bet your ass!!!
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Post by cjm18 on Apr 24, 2018 16:11:16 GMT -5
Listen all you idiotic health care providers!!! Afrezza is the SAFEST and greatest thing out there. Make it available like it should be!!!!!!!! You bet your ass!!! Bravo.
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Post by robbmo on Apr 24, 2018 16:16:06 GMT -5
I think it might be even better/huger (if that's a word):
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. this would be holy chit. Yes, it would. I think I now know why David Kendall might have come over... :-)
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Post by celo on Apr 24, 2018 16:18:32 GMT -5
One question, if this is a week old and is such an important point for Afrezza, why didn't Mannkind PR it a week ago?
Nevermind it seems to be electronically signed today
This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. -------------------------------------------------------------------------------------------- /s/ ------------------------------------------------------------ JENNIFER R PIPPINS 04/24/2018
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