|
|
Post by lakers on Nov 30, 2015 19:56:38 GMT -5
PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM) clinicaltrials.gov/ct2/show/NCT02485327?term=SAR439065&rank=3This study has been completed.[ way ahead of Jan end 2016, the originally published FDA schedule] Sponsor: Sanofi Information provided by (Responsible Party): Sanofi ClinicalTrials.gov Identifier: NCT02485327 First received: June 25, 2015 Last updated: November 26, 2015Last verified: November 2015 History of Changes Responsible Party: Sanofi ClinicalTrials.gov Identifier: NCT02485327 History of Changes Other Study ID Numbers: PDY14329, 2015-001008-74, U1111-1168-4442 Study First Received: June 25, 2015 Last Updated: November 26, 2015 Health Authority: Germany: Federal Institute for Drugs and Medical Devices United States: Food and Drug Administration Locations Germany Investigational Site Number 276001 Mainz, Germany, 55116Sponsors and Collaborators Sanofi Investigators Study Director: Clinical Sciences & Operations Sanofi Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus clinicaltrials.gov/ct2/show/NCT02470637?term=SAR439065&rank=1This study has been completed.[way ahead of Dec end 2015, the originally published FDA schedule]Sponsor: Sanofi Information provided by (Responsible Party): Sanofi ClinicalTrials.gov Identifier: NCT02470637 First received: June 10, 2015 Last updated: September 29, 2015Last verified: September 2015 History of Changes Locations Germany Investigational Site Number 276001 Neuss, Germany, 41460 Sponsors and Collaborators Sanofi Investigators Study Director: Clinical Sciences & Operations Sanofi Responsible Party: Sanofi ClinicalTrials.gov Identifier: NCT02470637 History of Changes Other Study ID Numbers: PDY14324, 2015-000231-33, U1111-1166-5431 Study First Received: June 10, 2015 Last Updated: September 29, 2015 Health Authority: Germany: Ethics Commission United States: Food and Drug Administration |
|
|
|
Post by mnholdem on Nov 30, 2015 20:10:46 GMT -5
Good news. Now, when do you suppose Sanofi will publish the results? The FDA did state that certain results could result in label changes, so I expect Sanofi, MannKind and FDA will also meet to discuss the data.
|
|
|
|
Post by lakers on Nov 30, 2015 20:18:50 GMT -5
Good news. Now, when do you suppose Sanofi will publish the results? The FDA did state that certain results could result in label changes, so I expect Sanofi, MannKind and FDA will also meet to discuss the data. Sanofi wanted a better label before EMA MAA filing. When they do, they will notify Mnkd who in turn most likely will ... They are on track ... Don't be pigeon-holed in the U.S. only. The more countries the merrier. Imagine 12 countries of $20.84M annual rev each = $250M qualifying for the first $250M milestone. $$ bonus for $$ milestone. Bootstrapping process ... Centralised Health Care systems, not fragmented as PBMs in the U.S. |
|
|
|
Post by dreamboatcruise on Nov 30, 2015 20:29:20 GMT -5
Good news. Now, when do you suppose Sanofi will publish the results? The FDA did state that certain results could result in label changes, so I expect Sanofi, MannKind and FDA will also meet to discuss the data. Unfortunately, the clamp study really won't show anything new. This is highly unlikely to result in any label change. The PD profile was already in the prescribing information. This is just additional data that will further validate the PD chart we all love so much. I would like to think that the pediatric study might have been designed to actually show superiority, but I temper even that expectation because of a comment on one conference call where MNKD stated that all the "required" FDA trials would be started before the label improvement one(s) seeming to indicate they would not be dual purpose. Maybe the pediatric or some other less official trials or observational studies will generate data that will be used with payers, if not for actual label improvement. Can't doctors publish observational studies as such in respected medical journals? It would seem some of the early adopter doctors (such as ones speaking at Adcom, Sam's doc, etc.) would have quite a lot of patient data that would show meaningful drops in A1c. Is that unpublishable since it wasn't in an FDA trial? |
|
|
|
Post by EveningOfTheDay on Nov 30, 2015 20:31:41 GMT -5
It is nice that the study was completed ahead of schedule. We certainly need all the good news we can get and in a hurry. Let's hope that the trial was designed to provide results that are significant and will move Afrezza ahead in the EMA approval game and possibly an improvement of the label across all jurisdictions. Thanks for the good news.
|
|
|
|
Post by lakers on Nov 30, 2015 20:33:37 GMT -5
Good news. Now, when do you suppose Sanofi will publish the results? The FDA did state that certain results could result in label changes, so I expect Sanofi, MannKind and FDA will also meet to discuss the data. Unfortunately, the clamp study really won't show anything new. This is highly unlikely to result in any label change. The PD profile was already in the prescribing information. This is just additional data that will further validate the PD chart we all love so much. I would like to think that the pediatric study might have been designed to actually show superiority, but I temper even that expectation because of a comment on one conference call where MNKD stated that all the "required" FDA trials would be started before the label improvement one(s) seeming to indicate they would not be dual purpose. Maybe the pediatric or some other less official trials or observational studies will generate data that will be used with payers, if not for actual label improvement. Can't doctors publish observational studies as such in respected medical journals? It would seem some of the early adopter doctors (such as ones speaking at Adcom, Sam's doc, etc.) would have quite a lot of patient data that would show meaningful drops in A1c. Is that unpublishable since it wasn't in an FDA trial? Anecdotal evidence is not admissible for NEJM, Matt has said. You can dig it up. 2 recently completed studies were carried out in Germany for a reason... |
|
|
|
Post by dreamboatcruise on Nov 30, 2015 20:34:39 GMT -5
Yes... this is good news because of the very probably connection with these being required for EMA approval.
|
|
|
|
Post by EveningOfTheDay on Nov 30, 2015 20:36:01 GMT -5
Unfortunately, the clamp study really won't show anything new. This is highly unlikely to result in any label change. The PD profile was already in the prescribing information. This is just additional data that will further validate the PD chart we all love so much. I would like to think that the pediatric study might have been designed to actually show superiority, but I temper even that expectation because of a comment on one conference call where MNKD stated that all the "required" FDA trials would be started before the label improvement one(s) seeming to indicate they would not be dual purpose. Maybe the pediatric or some other less official trials or observational studies will generate data that will be used with payers, if not for actual label improvement. Can't doctors publish observational studies as such in respected medical journals? It would seem some of the early adopter doctors (such as ones speaking at Adcom, Sam's doc, etc.) would have quite a lot of patient data that would show meaningful drops in A1c. Is that unpublishable since it wasn't in an FDA trial? Well, there goes part of my hopes, but I would, nonetheless, take this as a positive event, pending published results. |
|
|
|
Post by rrtzmd on Nov 30, 2015 20:37:24 GMT -5
Good news. Now, when do you suppose Sanofi will publish the results? The FDA did state that certain results could result in label changes, so I expect Sanofi, MannKind and FDA will also meet to discuss the data. Unfortunately, the clamp study really won't show anything new. This is highly unlikely to result in any label change. The PD profile was already in the prescribing information. This is just additional data that will further validate the PD chart we all love so much. I would like to think that the pediatric study might have been designed to actually show superiority, but I temper even that expectation because of a comment on one conference call where MNKD stated that all the "required" FDA trials would be started before the label improvement one(s) seeming to indicate they would not be dual purpose. Maybe the pediatric or some other less official trials or observational studies will generate data that will be used with payers, if not for actual label improvement. Can't doctors publish observational studies as such in respected medical journals? It would seem some of the early adopter doctors (such as ones speaking at Adcom, Sam's doc, etc.) would have quite a lot of patient data that would show meaningful drops in A1c. Is that unpublishable since it wasn't in an FDA trial? Docs can do any kind of study they want and publish any kind of data they want -- presuming of course that some journal thinks it's worth publishing. Right now, more worrisome, I would think, is the near total lack of comment one way or another about afrezza from any branch of medicine. |
|
|
|
Post by rockstarrick on Nov 30, 2015 20:59:43 GMT -5
Good news. Now, when do you suppose Sanofi will publish the results? The FDA did state that certain results could result in label changes, so I expect Sanofi, MannKind and FDA will also meet to discuss the data. Unfortunately, the clamp study really won't show anything new. This is highly unlikely to result in any label change. The PD profile was already in the prescribing information. This is just additional data that will further validate the PD chart we all love so much. I would like to think that the pediatric study might have been designed to actually show superiority, but I temper even that expectation because of a comment on one conference call where MNKD stated that all the "required" FDA trials would be started before the label improvement one(s) seeming to indicate they would not be dual purpose. Maybe the pediatric or some other less official trials or observational studies will generate data that will be used with payers, if not for actual label improvement. Can't doctors publish observational studies as such in respected medical journals? It would seem some of the early adopter doctors (such as ones speaking at Adcom, Sam's doc, etc.) would have quite a lot of patient data that would show meaningful drops in A1c. Is that unpublishable since it wasn't in an FDA trial? I believe continuous glucose monitors are required for the pediatric trials, they must be required for a reason. None of the other clinical trials have required them, I wonder why ?? Wouldnt that be something, every kid in the trial officially hitting high 5's without needles !! I can't wait !! |
|
|
|
Post by dreamboatcruise on Nov 30, 2015 21:08:47 GMT -5
rockstarrick... absolutely. That is very encouraging. I don't know what they've got up their sleeve regarding the use of CGM... but I sure like what I think they could have planned... better dosing protocols, data on lower postprandial spikes and fewer between meal hypos. Even if it is a trail with all kids, I would think it would make doctors sit up and pay attention for the wider implication. As glum as many of my posts seem, one of the reasons I hold firm at this point is I still think there are possibilities for catalysts, the timing of which would be hard for me to predict. I wouldn't say I have confidence in anything near term since we are told so little, but I would fear selling now for hopes of buying back later because surprises are possible.
|
|
|
|
Post by trondisc on Nov 30, 2015 21:09:47 GMT -5
I feel like bad or good news the market punishes MannKind. I'm wondering if Sanofi is ultimately not the answer to unlock MannKind's true hidden value. If Al Mann were smart he would have already been seeking multiple partnerships by now. I don't know which way to guess this story will go.
|
|
|
|
Post by stevil on Nov 30, 2015 21:22:09 GMT -5
Does anyone know why SNY is doing all of this before they launch rather than concordantly? I honestly can't tell if this is good news ha. It would seem to be proof of their commitment, but are they doing it out of necessity or out of ambition?
Are these trials going to act as keys to open up the hypothetical floodgates or are they just trying to be productive while they bide their time, waiting for _____ to happen?
It could make sense that they're firing up the engines and waiting for a label change. Is that the overall sense of what this is about?
Or do we think that we're shifting our focus more to the Euro/Asian market and hoping to find success there while America catches up?
|
|
|
|
Post by dreamboatcruise on Nov 30, 2015 21:36:44 GMT -5
Does anyone know why SNY is doing all of this before they launch rather than concordantly? I honestly can't tell if this is good news ha. It would seem to be proof of their commitment, but are they doing it out of necessity or out of ambition? Are these trials going to act as keys to open up the hypothetical floodgates or are they just trying to be productive while they bide their time, waiting for _____ to happen? It could make sense that they're firing up the engines and waiting for a label change. Is that the overall sense of what this is about? Or do we think that we're shifting our focus more to the Euro/Asian market and hoping to find success there while America catches up? I believe this was an FDA required post marketing study, but I seem to remember something that indicated it may be dual purpose, being required for EMA approval as well. I don't think it indicates anything other than that at the time it was started SNY was doing the things required to keep selling Afrezza and expand internationally. I don't think SNY can "wait" for a label change. That would require being very proactive. |
|
|
|
Post by mnholdem on Nov 30, 2015 23:14:45 GMT -5
Good news. Now, when do you suppose Sanofi will publish the results? The FDA did state that certain results could result in label changes, so I expect Sanofi, MannKind and FDA will also meet to discuss the data. Unfortunately, the clamp study really won't show anything new. This is highly unlikely to result in any label change. The PD profile was already in the prescribing information. This is just additional data that will further validate the PD chart we all love so much.
From the FDA description of Post-Marketing Requirement #2:
"Conduct a dose-ranging PK-PD euglycemic glucose-clamp trial to characterize the dose-response of Afrezza relative to subcutaneous insulin in patients with type 1 diabetes. Select at least three to four doses for each route of insulin administration to ensure both the linear and curvilinear portions of the dose-response curves are adequately captured and characterized. Compare the dose-response curves for Afrezza and subcutaneous insulin noting the dose at which the response becomes curvilinear for each. These data may impact labeling recommendations for dosing and thereby mitigate the risk of diabetic ketoacidosis, which has been observed with Afrezza."
This particular post-marketing trial will NOT demonstrate superiority, but results may still lead to labeling recommendations for dosing, meaning that the FDA may loosen up some of the allowable claims that Sanofi can market for mealtime use. I also wouldn't discount the importance of mitigating ketoacidosis when it comes to marketing Afrezza. We've already seen one example where Afrezza was used in an emergency manner to drop a patient from a dangerously high glucose level because of a fault CGM.
|
|
