|
|
Post by gonetotown on Sept 26, 2016 18:47:10 GMT -5
Someone here said a deadline was coming up and MNKD hasn't said anything about it. What exactly are they looking to change?
|
|
|
|
Post by rockstarrick on Sept 26, 2016 21:00:22 GMT -5
You must be referring to the label change that was discussed. I'm thinking a change from"rapid acting" to "ultra rapid acting" would be a good start.
No deadline that I'm aware of, I'm just glad they're going to do it.
|
|
|
|
Post by mnholdem on Sept 26, 2016 21:16:07 GMT -5
Someone here said a deadline was coming up and MNKD hasn't said anything about it. What exactly are they looking to change? MannKind's CMO Dr. Raymond Urbanski stated the following at the 2Q16 earnings call: The data from these studies, for example, the population PK/PD model, provides information which we will use in subsequent studies such as our dose optimization trials. Additionally, we’ll be using these data as well as data we generated during Afrezza’s development program to submit a label change to the FDA in the September and October timeframe. We believe that this new label will better instruct physicians on how to optimally dose and titrate Afrezza and give us more of a competitive advantage within the marketplace.
Source: seekingalpha.com/article/3997467-mannkinds-mnkd-ceo-matthew-pfeffer-q2-2016-results-earnings-call-transcript?page=8 |
|
|
|
Post by omeshrin on Sept 26, 2016 22:04:29 GMT -5
Yes, they are going ahead with it as it's a must. I am hoping very soon, especially in light of MLB? I'm guessing they'd want to be able to legally make certain claims before then.
But Mannkind is keeping mum about specifics right now -- could be such a time-sensitive issue that for competitive reasons they don't want to disclose specifics and perhaps they can't, except for that the results will likely be before year end (is FDA review 30 working days?).
Cheers.
|
|
|
|
Post by gonetotown on Sept 27, 2016 9:32:12 GMT -5
Someone here said a deadline was coming up and MNKD hasn't said anything about it. What exactly are they looking to change? MannKind's CMO Dr. Raymond Urbanski stated the following at the 2Q16 earnings call: The data from these studies, for example, the population PK/PD model, provides information which we will use in subsequent studies such as our dose optimization trials. Additionally, we’ll be using these data as well as data we generated during Afrezza’s development program to submit a label change to the FDA in the September and October timeframe. We believe that this new label will better instruct physicians on how to optimally dose and titrate Afrezza and give us more of a competitive advantage within the marketplace.
Source: seekingalpha.com/article/3997467-mannkinds-mnkd-ceo-matthew-pfeffer-q2-2016-results-earnings-call-transcript?page=8Unfortunately, that doesn't explain a lot. So the new label will add instructions on dosing but otherwise remain the same? And that's the first I have read about any "dose optimization trials." It doesn't seem to make sense to apply now for a label change to optimize dosing when trials for optimizing dosing are still being planned. |
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Sept 27, 2016 9:38:46 GMT -5
The label change discussion has been vague imo. What's needed and what everyone wants to hear about is the "rapid acting" aspect of the label. What's been referenced is optimal dosing and titration.
|
|
|
|
Post by mnholdem on Sept 27, 2016 11:07:23 GMT -5
If they chose to, MannKind could break down the data for multiple submissions to the FDA. An efficacy review would take longer than approval of the other trial data. Some of the data could be quickly approved and updated information (i.e. graphs, data) could replace the older data that is currently in the label. Time is of the essence and I suspect that MannKind wants some quick label improvement now for marketing purposes with additional label changes later. Look for MannKind to submit multiple label submissions to the FDA.
 |
|
|
|
Post by matt on Sept 27, 2016 11:56:29 GMT -5
The timing is not as fast as many are making it sound. FDA categorizes changes to approved labels and has different approval standards for each. The 30-day category is for relatively minor changes, such as a new corporate logo of the color of ink used in printing the label. Those are considered minor changes and can go into effect on the 30th day unless FDA objects.
The kind of label change Mannkind is looking for requires a PAS (prior approval supplement) and there is no automatic time deadline for those. Internally the FDA targets approving 90% of all PAS submissions within six months, but 10% will take longer. Don't expect a substantive change in marketing claims on the label to be approved this year.
|
|
|
|
Post by peppy on Sept 27, 2016 12:02:08 GMT -5
The timing is not as fast as many are making it sound. FDA categorizes changes to approved labels and has different approval standards for each. The 30-day category is for relatively minor changes, such as a new corporate logo of the color of ink used in printing the label. Those are considered minor changes and can go into effect on the 30th day unless FDA objects. The kind of label change Mannkind is looking for requires a PAS (prior approval supplement) and there is no automatic time deadline for those. Internally the FDA targets approving 90% of all PAS submissions within six months, but 10% will take longer. Don't expect a substantive change in marketing claims on the label to be approved this year. Matt and or all. Is there any website or documentation were a submittal for label change can be seen by the public? It would be uplifting to see documentation of submission or application.
Additionally the clamp studies were an FDA requirement at time of approval. Could the clamp study results be in any way considered and fda demanded phase 4 study? www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf
Pep
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Sept 27, 2016 12:25:13 GMT -5
The timing is not as fast as many are making it sound. FDA categorizes changes to approved labels and has different approval standards for each. The 30-day category is for relatively minor changes, such as a new corporate logo of the color of ink used in printing the label. Those are considered minor changes and can go into effect on the 30th day unless FDA objects. The kind of label change Mannkind is looking for requires a PAS (prior approval supplement) and there is no automatic time deadline for those. Internally the FDA targets approving 90% of all PAS submissions within six months, but 10% will take longer. Don't expect a substantive change in marketing claims on the label to be approved this year. Matt sums it up perfectly. For more details and plenty of boredom, additional reading perfect for treating insomnia is here: mnkd.proboards.com/thread/2366/label-changes-afrezza |
|
|
|
Post by kc on Sept 27, 2016 13:02:12 GMT -5
When they do file and get approval it would be found here. So keep your eyes tuned to this FDA site.
09/01/2016: Safety labeling change (SLC) data on the Web is now be available view, search, and download, as close to the day of the labeling supplement approval as possible. Please visit the new database to obtain the most recent label changes. More information about the database
www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/
MANNKIND
* MANNKIND CORP
AFREZZA, INSULIN RECOMBINANT HUMAN
Labeling Section:
Boxed Warning
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
|
|
|
|
Post by dreamboatcruise on Sept 27, 2016 15:35:17 GMT -5
Is it remotely possible they could use the simulation results along with the clamp studies to get a label change that says that dosing can occur after a meal is started. Urbanski did say Sept-Oct and competitive advantage. Some PWD have problems with dosing premeal and then having the actual eating be delayed or misjudging the amount of food, causing risks of hypos. So a change of dosing instructions that one may wait until the meal has started, or even concluded, could be viewed as a competitive advantage... though perhaps not a competition killing change that would make it difficult for payers to still require hoops.
|
|
|
|
Post by mnholdem on Sept 27, 2016 16:14:38 GMT -5
An excellent analysis, IMO.
|
|
|
|
Post by gonetotown on Sept 27, 2016 20:57:18 GMT -5
So, derived from the replies, my sense is that no one really knows what changes are going to be requested, what data will be used to support the requests, or when the requests will actually be made. The only thing certain is that whatever is done, it will be a long time before any actual label change is seen. Is that a fair assessment?
|
|
|
|
Post by straightly on Sept 28, 2016 1:31:08 GMT -5
Just curious.
Can MNKD apply for a label change and issue an news release to say
"We have applied for a label change to label Afrezza as Ultra Rapid Insulin. Afrezza is an insulin with an outsulin component. We have gathered sufficient supporting evidence to show that Afrezza stands tour in its own class, an ultra rapid acting insulin. Please take notice that many of our competitors have wanted to speed up the action time of their insulin. Unfortunately for them and for all diabetes, their efforts had yield very limited success and they are still trying. With the ultra rapid profile of Afrezza, the good news has arrived for diabetes patients that they will now have an alternative to better manage their A1C, all without sticking themselves with a needle. Of course, there is no guarantee but we are confident that FDA will approve it on fast track, given the fact that FDA had delayed Afrezza for so long before its approval and caused so many difficulties for man(n)kind."
That probably will move our PPS up. Kind of a fun thought.
Just curious like I said.
|
|
