People should simply read the documentation if they want to see what is being waived -
Afrezza REMS
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 starting on AFREZZA
- 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
The REMS letter then describes how this must be accomplished and requires a progress report at the 18 month, 3 year, and 7 year points. What the new letter is stating is that these actions have been completed and are no long outstanding so the 7 year report is not required.
I think it releases Mannkind from having to maintain the Afrezzarems.com website and display the REMS notice at all scientific meetings. I suspect the pediatric comment is there because the now completed communication plan is for Afrezza and since there is no separate pediatric version there is no need for a new REMS.
What it does not do it touch the the label so black box, etc. remains. This might be Dr Kendall cleaning up something that should have been done a while ago since I think all of these actions were completed soon after launch, just that nobody followed up with the FDA.
I believe you hit it.
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.
Reference ID: 3533688
NDA 022472 Page 7
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
The requirements for assessments of an approved REMS under section 505-1(g)(3) include with respect to each goal included in the strategy, an assessment of the extent to which the approved strategy, including each element of the strategy, is meeting the goal or whether 1 or more such goals or such elements should be modified.
We remind you that in addition to the assessments submitted according to the timetable included in the approved REMS, you must submit a REMS assessment and may propose a modification to the approved REMS when you submit a supplemental application for a new indication for use as described in section 505-1(g)(2)(A) of the FDCA.
If the assessment instruments and methodology for your REMS assessments are not included in the REMS supporting document, or if you propose changes to the submitted assessment instruments or methodology, you should update the REMS supporting document to include specific assessment instrument and methodology information at least 90 days before the assessments will be conducted. Updates to the REMS supporting document may be included in a new document that references previous REMS supporting document submission(s) for unchanged portions. Alternatively, updates may be made by modifying the complete previous REMS supporting document, with all changes marked and highlighted. Prominently identify the submission containing the assessment instruments and methodology with the following wording in bold capital letters at the top of the first page of the submission:
NDA 022472 REMS CORRESPONDENCE
(insert concise description of content in bold capital letters, e.g., UPDATE TO REMS SUPPORTING DOCUMENT - ASSESSMENT METHODOLOGY)
Prominently identify the submission containing the REMS assessments or proposed modifications with the following wording in bold capital letters at the top of the first page of the submission:
NDA 022472 REMS ASSESSMENT
NEW SUPPLEMENT FOR NDA 022472 PROPOSED REMS MODIFICATION
NEW SUPPLEMENT (NEW INDICATION FOR USE) FOR NDA 022472
REMS ASSESSMENT
PROPOSED REMS MODIFICATION (if included)