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Post by hopetoretire on May 16, 2016 17:44:00 GMT -5
I think maybe they mean not to mix another longer acting insulin - like 'don't keep taking Lantus while taking Toujeo'. But, it sounded to me like "forget about trying Afrezza, we hate it and want it to fail, so just go with our new wonder-drug Toujeo because we are putting all our eggs in this basket".
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Post by gamblerjag on May 16, 2016 19:33:16 GMT -5
I think it always said that.
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Post by agedhippie on May 16, 2016 19:44:09 GMT -5
This is nothing to do with taking Afrezza or any other insulin with Toujeo, it's a standard warning on all insulin analogs. You can find exactly the same warning on Tresiba. The warning is about physically combining the insulins, not taking them concurrently. In the old days you sometimes drew up both Regular and NPH insulin into the same syringe so you saved an injection. You cannot do this with modern insulins.
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Post by brotherm1 on May 16, 2016 21:27:24 GMT -5
Afrezza was determined by FDA to be non-inferior to lispro, but this data should be marketable as a rebuttal.  Thanks holdem. Thanks for the clinical study link Peppy. If I am understanding this subject correctly, this certainly sounds to me that this could be one big step for Mannkind and one large leap for mankind. |
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Post by peppy on May 16, 2016 22:27:33 GMT -5
cathode posted this in another thread, also pertains to the abstracts. Regarding Afrezza: what can be said.
The PK/PD profile section is generally positive but still not as great as we know it to be.
From 12.3 in the label: "The maximum serum insulin concentration was reached by 12–15 minutes after inhalation of AFREZZA 8 units and serum insulin concentrations declined to baseline by approximately 180 minutes." [Subcutaneous insulin is shown to have maximum concentrations 45-75 minutes after injection; baseline achieved at around 210-240 minutes] <-- added by me
From 12.3: "Systemic insulin disposition (median terminal half-life) following oral inhalation of AFREZZA 4 and 32 units was 28–39 minutes, and 145 minutes for subcutaneous regular human insulin 15 units."
I see nothing wrong with the phrase "Afrezza is faster absorbing than Insulin Lispro."
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Post by tayl5 on May 16, 2016 23:38:35 GMT -5
So to be perfectly clear: Are these absracts the result of completed studies that were approved by the FDA and will the results of these studies be able to be listed on the drug packaging/inserts? Sorry to ask so many questions. It would be irresponsible for anyone in science or medicine to present a poster or other communication where the title reflects the hypothesis rather than the conclusion. If that were allowed symposia, conferences and the scientific literature wouldn't be any better than faux news. |
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Post by mnholdem on May 17, 2016 7:11:46 GMT -5
In January 2016 the FDA released its long-awaited industry guidance publication, "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices".
Link: www.fda.gov/RegulatoryInformation/Guidances/ucm125126.htm
While the six articles to be published at the 2016 ADA in New Orleans may or may not not fall under the description, "Unapproved New Uses of Approved Drugs" the FDA document nonetheless provides useful guidance on the distribution of scientific or medical reference publications.
You can use the link above if you wish to read the entire document (it's not very lengthy). Here is an excerpt:
B. Manner in which to Disseminate Scientific and Medical Information
Scientific or medical information that is distributed should:
- be in the form of an unabridged reprint, copy of an article, or reference publication;
- not be marked, highlighted, summarized, or characterized by the manufacturer in any way (except to provide the accompanying disclosures discussed in this section);
- be accompanied by the approved labeling for the drug or medical device;
- be accompanied, when such information exists, by a comprehensive bibliography of publications discussing adequate and well-controlled clinical studies published in medical journals or medical or scientific texts about the use of the drug or medical device covered by the information disseminated (unless the information already includes such a bibliography);
- be disseminated with a representative publication, when such information exists, that reaches contrary or different conclusions regarding the unapproved use; especially those in cases where the conclusions of articles or texts to be disseminated have been specifically called into question by another published article(s) or text(s); and
- be distributed separately from information that is promotional in nature. For example, if a sales representative delivers a reprint to a physician in his office, the reprint should not be physically attached to any promotional material the sales representative uses or delivers during the office visit and should not be the subject of discussion between the sales representative and the physician during the sales visit. Similarly, while reprints may be distributed at medical or scientific conferences in settings appropriate for scientific exchange, reprints should not be distributed in promotional exhibit halls or during promotional speakers' programs.
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Post by cathode on May 17, 2016 7:51:10 GMT -5
cathode posted this in another thread, also pertains to the abstracts. Regarding Afrezza: what can be said.
The PK/PD profile section is generally positive but still not as great as we know it to be.
From 12.3 in the label: "The maximum serum insulin concentration was reached by 12–15 minutes after inhalation of AFREZZA 8 units and serum insulin concentrations declined to baseline by approximately 180 minutes." [Subcutaneous insulin is shown to have maximum concentrations 45-75 minutes after injection; baseline achieved at around 210-240 minutes] <-- added by me
From 12.3: "Systemic insulin disposition (median terminal half-life) following oral inhalation of AFREZZA 4 and 32 units was 28–39 minutes, and 145 minutes for subcutaneous regular human insulin 15 units."
I see nothing wrong with the phrase "Afrezza is faster absorbing than Insulin Lispro."
In the same PK/PD section of the label (page 4) it states "Despite the faster absorption of insulin (PK) from Afrezza, the onset of activity (PD) was comparable to insulin lispro". The results to be presented at the ADA seem to contradict that, which is promising. The label also doesn't have any specifics on the duration of activity of Afrezza compared to lispro. It has a graph, but not words. One of the late-breaking abstracts addresses the duration of activity. |
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Post by lakers on May 18, 2016 0:54:43 GMT -5
American Diabetes Association - 76th Scientific Sessions Home Print Page
Share Page
931-P / 931 - Technosphere® Inhaled Human Insulin Has a More Rapid Onset of Action Than Subcutaneous Insulins: Meta-analysis of Clamp Data from Three Clinical Studies
Itinerary
June 11, 2016, 11:30 - 1:30 PM
Authors
YOUSSEF HIJAZI, ANDERS BOSS, THOMAS KLABUNDE, RAPHAEL DAHMEN, DIETHER RUEPPEL, ROBERT A. BAUGHMAN, Frankfurt, Germany, Bridgewater, NJ, Danbury, CT
Disclosures
Y. Hijazi: Employee; Author; Sanofi. A. Boss: Employee; Author; Sanofi. T. Klabunde: Employee; Author; Sanofi. R. Dahmen: Employee; Author; Sanofi. D. Rueppel: Employee; Author; Sanofi. R.A. Baughman: Employee; Author; MannKind Corporation.
937-P / 937 - Effects of Inhaled Technosphere Insulin (TI) on the Pulmonary Function of Patients with T1D and T2D
Itinerary
June 11, 2016, 11:30 - 1:30 PM
Authors
JOSEPH BRAIN, NIKHIL AMIN, JOHN STEWART, ELENA NIKONOVA, ROBERT WISE, Boston, MA, Danbury, CT, Laval, QC, Canada, Morristown, NJ, Baltimore, MD
Disclosures
J. Brain: Consultant; Author; Sanofi U.S., MannKind Corporation. N. Amin: Employee; Author; MannKind Corporation. J. Stewart: Employee; Author; Sanofi Canada. Stock/Shareholder; Author; Sanofi Canada. E. Nikonova: Other Relationship; Author; Artech Information Systems, LLC, under contract with Sanofi US, Inc. R. Wise: Consultant; Author; Sanofi U.S., MannKind Corporation.
973-P / 973 - The Impact of Baseline Lung Function on Outcomes with Inhaled Technosphere Insulin (TI)
Itinerary
June 11, 2016, 11:30 - 1:30 PM
Authors
JOSEPH BRAIN, NIKHIL AMIN, JOHN STEWART, ELENA NIKONOVA, ROBERT WISE, Boston, MA, Danbury, CT, Laval, QC, Canada, Morristown, NJ, Baltimore, MD
Disclosures
J. Brain: Consultant; Author; Sanofi U.S., MannKind Corporation. N. Amin: Employee; Author; MannKind Corporation. J. Stewart: Employee; Author; Sanofi Canada. Stock/Shareholder; Author; Sanofi Canada. E. Nikonova: Other Relationship; Author; Artech Information Systems, LLC, under contract with Sanofi US, Inc. R. Wise: Consultant; Author; Sanofi U.S., MannKind Corporation.
975-P / 975 - A Population PK/PD Model of Technosphere® Insulin Administered to Healthy Subjects
Itinerary
June 11, 2016, 11:30 - 1:30 PM
Authors
DIETHER RUEPPEL, RAPHAEL DAHMEN, ANDERS BOSS, MARSHALL GRANT, ROBERT BAUGHMAN, THOMAS KLABUNDE, Frankfurt, Germany, Bridgewater, NJ, Danbury, CT
Disclosures
D. Rueppel: Employee; Author; Sanofi. R. Dahmen: Employee; Author; Sanofi. A. Boss: Employee; Author; Sanofi. M. Grant: Employee; Author; Mannkind Corporation. R. Baughman: Employee; Author; MannKind Corporation. T. Klabunde: Employee; Author; Sanofi.
100-LB / 100 - Technosphere Insulin Inhalation Powder (TI) Displays Earlier Onset and Shorter Duration than Insulin Lispro (Lispro)
Itinerary
June 12, 2016, 12:00 - 2:00 PM
Authors
ROBERT A. BAUGHMAN, TIM HEISE, MARSHALL L. GRANT, PHILIPPE GROSJEAN, LAURENT PERRIN, YOUSSEF HIJAZI, BRITTA GOEBEL, RAPHAEL DAHMEN, Danbury, CT, Neuss, Germany, Paris, France, Frankfurt, Germany
Disclosures
R.A. Baughman: Employee; Author; MannKind Corporation. T. Heise: Consultant; Author; Profil Institute for Clinical Research, Inc. M.L. Grant: Employee; Author; MannKind Corporation. P. Grosjean: Employee; Author; Sanofi-Aventis Deutschland GmbH. L. Perrin: Employee; Author; Sanofi-Aventis Deutschland GmbH. Y. Hijazi: Employee; Author; Sanofi-Aventis Deutschland GmbH. B. Goebel: Employee; Author; Sanofi-Aventis Deutschland GmbH. R. Dahmen: Employee; Author; Sanofi-Aventis Deutschland GmbH.
102-LB / 102 - Within-Subject Variability of Insulin Exposure and Metabolic Activity following Replicate Doses of Technosphere® Insulin Inhalation Powder (TI) in Patients with T1DM
Itinerary
June 12, 2016, 12:00 - 2:00 PM
Authors
ROBERT A. BAUGHMAN, MARSHALL GRANT, LEONA PLUM-MORSCHEL, VIRGINIE ESPOSITO, ASTRID DELFOLIE, YOUSSEF HIJAZI, RAPHAEL DAHMEN, Danbury, CT, Mainz, Germany, Paris, France, Frankfurt, Germany
Disclosures
R.A. Baughman: Employee; Author; MannKind Corporation. M. Grant: Employee; Author; MannKind Corporation. L. Plum-Morschel: Employee; Author; Profil Institute for Clinical Research, Inc. V. Esposito: Employee; Author; Sanofi-Aventis Deutschland GmbH. A. Delfolie: Employee; Author; Sanofi-Aventis Deutschland GmbH. Y. Hijazi: Employee; Author; Sanofi-Aventis Deutschland GmbH. R. Dahmen: Employee; Author; Sanofi-Aventis Deutschland GmbH.
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Post by pantaloons on May 19, 2016 14:00:22 GMT -5
I have two questions regarding these new abstracts:
1) At what point can we expect MNKD to submit these results for peer-review?
2) How will the FDA use these data to change the label on Afrezza? How long will this take?
Any insight would be greatly appreciated!
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Post by agedhippie on May 19, 2016 15:55:48 GMT -5
I have two questions regarding these new abstracts: 1) At what point can we expect MNKD to submit these results for peer-review? 2) How will the FDA use these data to change the label on Afrezza? How long will this take? Any insight would be greatly appreciated! Papers are peer-reviewed (expect to see most if not all in Diabetes Care), but posters are not. |
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Post by pantaloons on May 19, 2016 20:49:25 GMT -5
I have two questions regarding these new abstracts: 1) At what point can we expect MNKD to submit these results for peer-review? 2) How will the FDA use these data to change the label on Afrezza? How long will this take? Any insight would be greatly appreciated! Papers are peer-reviewed (expect to see most if not all in Diabetes Care), but posters are not. Would it be worthwhile for MNKD to put together these results as a publication for peer-review? How would these results affect future label changes via the FDA? |
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Post by mnholdem on May 19, 2016 21:13:08 GMT -5
pantaloonsI seems to me that you don't realize that these ARE peer-reviewed publications. Each publication has multiple authors who have collaborated with each other in what is often meta-analysis of trial data related to Afrezza. Perhaps what you mean to suggest is that these findings should be published in major medical journals for dissemination to other physicians or "peers" in this branch of medicine? Regardless, it's important to understand that these publications carry weight precisely because the findings published in them have been peer-reviewed. Good fortune to you.
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Post by agedhippie on May 19, 2016 21:34:49 GMT -5
pantaloons I seems to me that you don't realize that these ARE peer-reviewed publications. Each publication has multiple authors who have collaborated with each other in what is often meta-analysis of trial data related to Afrezza. Perhaps what you mean to suggest is that these findings should be published in major medical journals for dissemination to other physicians or "peers" in this branch of medicine? Regardless, it's important to understand that these publications carry weight precisely because the findings published in them have been peer-reviewed. Good fortune to you. The authors don't count for peer review. The peer reviewers cannot be associated with the authors or any commercial sponsor of the paper. It's a thankless job and usually editors bully people into by making peer reviewing a couple of papers a condition of publishing your paper. I once was an academic so I've been through this. When I was doing this posters didn't get peer reviewed since they are work in progress or meant to spark discussion. If you are part way through a research project you might produce a poster - once it's squared away you would produce a paper. |
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Post by pantaloons on May 19, 2016 21:53:47 GMT -5
pantaloons I seems to me that you don't realize that these ARE peer-reviewed publications. Each publication has multiple authors who have collaborated with each other in what is often meta-analysis of trial data related to Afrezza. Perhaps what you mean to suggest is that these findings should be published in major medical journals for dissemination to other physicians or "peers" in this branch of medicine? Regardless, it's important to understand that these publications carry weight precisely because the findings published in them have been peer-reviewed. Good fortune to you. I appreciate the response, and I'll be the first to admit that I'm a bit ignorant to how results from clinical research are disseminated. My background is in the basic sciences, and posters are not peer-reviewed in the basic sciences. That is not to say that the results are not substantial, but rather that they have not been "formally accepted" yet. Generally, in the basic sciences, poster presentations are en route to peer-reviewed publications. I'm interested in knowing how clinical research (both in academia and industry) results will affect labeling down the road. I realize the basic and clinical sciences research are worlds apart! |
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