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Post by LosingMyBullishness on Jan 3, 2017 17:53:51 GMT -5
mnholdem, your post triggered an exciting possibility that had not occurred to me before although it should have. Whatever results that are determined in the pediatric study can easily be used to improve the label for adults. If they approve it for kids, adult use is a no brainer. So if MannKind, JDRF and the FDA can established protocols that showcase Afrezza in its highest and best use i.e. lower hypoglycemia events, markedly improved A1c, improved glucose control, we won't need another study to improve the overall label. JMHO I would be surprised if you could change the adult label on the basis of the pediatric trial. The trial data is for a pediatric population, not an adult population. For a start children tend to be far more insulin sensitive than adults because of body weight. I think changing the adult label will require further trials to demonstrate the improvement in an adult population. I would happily take a superiority finding for pediatrics though - it's a start. Aged, The point is valid as it is not about formally changing the adult label but ! Being a strong signal to adults that Afrezza is safe even for kids. Adults see little harm in using baby powder and baby shampoo. It is about perception. Adult patient would look at the label differently when it is safe for kids.
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Post by mnholdem on Jan 3, 2017 20:50:47 GMT -5
mnholdem, your post triggered an exciting possibility that had not occurred to me before although it should have. Whatever results that are determined in the pediatric study can easily be used to improve the label for adults. If they approve it for kids, adult use is a no brainer. So if MannKind, JDRF and the FDA can established protocols that showcase Afrezza in its highest and best use i.e. lower hypoglycemia events, markedly improved A1c, improved glucose control, we won't need another study to improve the overall label. JMHO But the pediatrics trial is just a phase 1 study, isn't it? That's just to determine whether it's safe for further studies to determine effects on A1c, etc. I remember reading that Sanofi had recruited patients for Phase I trials at the University of Colorado. MannKind's pipeline graphic on the company website shows that they are at Phase II in the post-market pediatrics studies:
Source: www.mannkindcorp.com/research-development/pipeline/
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Post by wildthing on Jan 3, 2017 21:36:44 GMT -5
But the pediatrics trial is just a phase 1 study, isn't it? That's just to determine whether it's safe for further studies to determine effects on A1c, etc. I remember reading that Sanofi had recruited patients for Phase I trials at the University of Colorado. MannKind's pipeline graphic on the company website shows that they are at Phase II in the post-market pediatrics studies:
Source: www.mannkindcorp.com/research-development/pipeline/
But the Sanofi trial NCT02527265 was phase 1 and was suspended before it was completed, wasn't it? Mannkind can't move to phase 2 until they complete phase 1, right?
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Post by seanismorris on Jan 3, 2017 22:46:43 GMT -5
The pediatric study is taking way to long...
The company is going to be out of business before its completed. The early phase of the trial should not require that many patients.
So, what I'm hearing is they have not figured out the dosing, or gotten enough interest in sigh ups... The 2U cartridge can't be the holdup, it's not like the production lines are bogged down.
I'd was incredibly high on this trial. I thought they could demonstrate good safety and the effectiveness of Afrezza, that could be presented to docs that would result in increased scripts across the board.
Instead another pathetic execution by MannKind. Tick-Tock, Tick-Tock
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Post by lakers on Jan 3, 2017 23:16:34 GMT -5
Some insights....
From: "Tran, Bao-Khanh" <BAO-KHANH.TRAN@UCDENVER.EDU> Date: January 25, 2016 at 4:13:08 PM PST
I apologize for the delay in response. Those definitely good question.
We are still currently still recruiting for our cohort I (ages 13-17). As far as starting for cohort II (ages 8-12) that is dependent on the data that we have collected for our cohort I.
As far as dosing, it depends on the child's carb to insulin ratio. Currently Afrezza's insulin dosing is equivalent to that of the rapid acting insulin drug 1:1 ratio of how you would usually dose with your rapid/short-acting insulin. As far as basal, the dosing should not change when enrolled in the study.
For the CGM, the model that is being used is the G4 however the data will be blinded therefore the child will not be able to see the data on the CGM.
As far as the partnership study will still continue its course for recruitment.
We are always happy to answer any questions you or your relative may have.
Thank you for your interest in our study!
Sincerely,
Bao-Khanh Tran, BS Professional Research Assistant for Dr. Wadwa Barbara Davis Center for Childhood Diabetes University of Colorado School of Medicine Mail Stop F527 1775 Aurora Court Aurora, CO 80045 Phone: 303-724-8095 bao-khanh.tran@ucdenver.edu
Sent: Wednesday, January 20, 2016 1:20 AM To: Tran, Bao-Khanh <BAO-KHANH.TRAN@UCDENVER.EDU> Subject: Is it too late to join Afrezza pediatric study?
Hi Bao-khanh,
Regarding the Afrezza pediatric study, have you finished recruiting and started trial for Phase one yet?
When will Phase 1 finish? When will Phase 2 start and finish?
What dosing at what time do you expect? For example do you need more Afrezza units per unit of basal drug? Do you inhale 10 mins after starting a meal? What CGM do you use?
If it's not too late, I can refer my relative to join the trial.
Now that Sanofi terminates partnership with Mannkind, who gonna manage and fund Phase 1 and 2?
Thanks,
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Post by rossomalley on Jan 3, 2017 23:35:05 GMT -5
Some insights.... I apologize for the delay in response. Those definitely good question. We are still currently still recruiting for our cohort I (ages 13-17). As far as starting for cohort II (ages 8-12) that is dependent on the data that we have collected for our cohort I. As far as dosing, it depends on the child's carb to insulin ratio. Currently Afrezza's insulin dosing is equivalent to that of the rapid acting insulin drug 1:1 ratio of how you would usually dose with your rapid/short-acting insulin. As far as basal, the dosing should not change when enrolled in the study. For the CGM, the model that is being used is the G4 however the data will be blinded therefore the child will not be able to see the data on the CGM. As far as the partnership study will still continue its course for recruitment. We are always happy to answer any questions you or your relative may have. Thank you for your interest in our study! Sincerely, Bao-Khanh Tran, BS Professional Research Assistant for Dr. Wadwa Barbara Davis Center for Childhood Diabetes University of Colorado School of Medicine Mail Stop F527 1775 Aurora Court Aurora, CO 80045 Phone: 303-724-8095 bao-khanh.tran@ucdenver.edu Sent: Wednesday, January 20, 2016 1:20 AM To: Tran, Bao-Khanh <BAO-KHANH.TRAN@UCDENVER.EDU> Subject: Is it too late to join Afrezza pediatric study? Hi Bao-khanh, Regarding the Afrezza pediatric study, have you finished recruiting and started trial for Phase one yet? When will Phase 1 finish? When will Phase 2 start and finish? What dosing at what time do you expect? For example do you need more Afrezza units per unit of basal drug? Do you inhale 10 mins after starting a meal? What CGM do you use? If it's not too late, I can refer my relative to join the trial. Now that Sanofi terminates partnership with Mannkind, who gonna manage and fund Phase 1 and 2? Thanks, When did you receive his response? You've left that important detail out. If in Jan of last year, its likely this all changed as JV began to wind down shortly thereafter, no?
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Post by wildthing on Jan 4, 2017 10:50:32 GMT -5
Some insights.... From: "Tran, Bao-Khanh" <BAO-KHANH.TRAN@UCDENVER.EDU> Date: January 25, 2016 at 4:13:08 PM PST I apologize for the delay in response. Those definitely good question. We are still currently still recruiting for our cohort I (ages 13-17). As far as starting for cohort II (ages 8-12) that is dependent on the data that we have collected for our cohort I. As far as dosing, it depends on the child's carb to insulin ratio. Currently Afrezza's insulin dosing is equivalent to that of the rapid acting insulin drug 1:1 ratio of how you would usually dose with your rapid/short-acting insulin. As far as basal, the dosing should not change when enrolled in the study. For the CGM, the model that is being used is the G4 however the data will be blinded therefore the child will not be able to see the data on the CGM. As far as the partnership study will still continue its course for recruitment. We are always happy to answer any questions you or your relative may have. Thank you for your interest in our study! Sincerely, Bao-Khanh Tran, BS Professional Research Assistant for Dr. Wadwa Barbara Davis Center for Childhood Diabetes University of Colorado School of Medicine Mail Stop F527 1775 Aurora Court Aurora, CO 80045 Phone: 303-724-8095 bao-khanh.tran@ucdenver.edu Sent: Wednesday, January 20, 2016 1:20 AM To: Tran, Bao-Khanh <BAO-KHANH.TRAN@UCDENVER.EDU> Subject: Is it too late to join Afrezza pediatric study? Hi Bao-khanh, Regarding the Afrezza pediatric study, have you finished recruiting and started trial for Phase one yet? When will Phase 1 finish? When will Phase 2 start and finish? What dosing at what time do you expect? For example do you need more Afrezza units per unit of basal drug? Do you inhale 10 mins after starting a meal? What CGM do you use? If it's not too late, I can refer my relative to join the trial. Now that Sanofi terminates partnership with Mannkind, who gonna manage and fund Phase 1 and 2? Thanks, This is a list of all the current trials at that Barbara Davis Center: www.ucdenver.edu/academics/colleges/medicalschool/centers/BarbaraDavis/Clinical/Pages/ClinicalResearch.aspxNothing about inhaled insulin or afrezza, so I'm guessing it was cancelled when Sanofi suspended their trial.
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Post by christopher on Jan 4, 2017 17:07:20 GMT -5
So the study starts in 2017. Most pediatric medications take about 5 to 8 years to get through the FDA trials and reviews before going to market. Does MNKD have the financial resources to hold out for that long?
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Post by mnholdem on Jan 4, 2017 17:19:22 GMT -5
I don't know where you get your information, but the original post-market pediatric trial for Afrezza was posted at the FDA website. It was in two parts, with the first Phase lasting approximately 3-4 months and then a 52-week second Phase. Sanofi's timeline that was filed with the FDA displayed about 18 months to expected completion. From the ClinicalTrials.gov site:
Afrezza Safety and Pharmacokinetics Study in Pediatric Patients This study has suspended participant recruitment. (Due to transfer of ownership of Afrezza IND & NDA back to MannKind Corporation, enrollment into the TDR14323 study was suspended)
Sponsor:Study Start Date: October 2015 Estimated Study Completion Date: August 2017 Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Detailed Description
The patients are expected to participate in the study for approximately 6 to 8 weeks from Screening to final follow-up visit.
Patients who completed 4 weeks of Afrezza treatment and have shown to be safe and well controlled with Afrezza + basal insulin will have the option to continue the extension treatment up to 1 year.
---
5 to 8 years of trials? Hardly. The API (insulin human) has been approved by the FDA as a safe product for pediatric treatment of diabetes mellitus and has been used in injection form (Novolin, Humalin) for decades.
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Post by lakers on Jan 4, 2017 17:54:01 GMT -5
An open-label pharmacokinetic (PK), and multiple-dose safety and tolerability dose-titration trial of Afrezza in pediatric patients ages 4 to 17 years (inclusive) with type 1 diabetes (Part 1), followed by a prospective, multicenter, open-label, randomized, controlled trial comparing the efficacy and safety of prandial Afrezza to prandial subcutaneous insulin aspart used in combination with subcutaneous basal insulin in pediatric patients 4 to 17 years old (inclusive) with type 1 or type 2 diabetes (Part 2). Part 2 of the trial should include a 4-week run-in phase and a 52-week randomized intervention phase. www.accessdata.fda.gov/scripts/cder/pmc/index.cfm
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Post by bioexec25 on Jan 4, 2017 18:56:19 GMT -5
So the study starts in 2017. Most pediatric medications take about 5 to 8 years to get through the FDA trials and reviews before going to market. Does MNKD have the financial resources to hold out for that long? Chris are you seriously saying a Phase IIIa or Phase IV trial is going to take 5-8 years?
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Post by lakers on Jan 4, 2017 19:24:39 GMT -5
An open-label pharmacokinetic (PK), and multiple-dose safety and tolerability dose-titration trial of Afrezza in pediatric patients ages 4 to 17 years (inclusive) with type 1 diabetes (Part 1), followed by a prospective, multicenter, open-label, randomized, controlled trial comparing the efficacy and safety of prandial Afrezza to prandial subcutaneous insulin aspart used in combination with subcutaneous basal insulin in pediatric patients 4 to 17 years old (inclusive) with type 1 or type 2 diabetes (Part 2). Part 2 of the trial should include a 4-week run-in phase and a 52-week randomized intervention phase. www.accessdata.fda.gov/scripts/cder/pmc/index.cfmThis is the only Pediatric Postmarket Requirements and Commitments Required Under: Pediatric Research Equity Act
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Post by cjm18 on Jan 4, 2017 20:07:06 GMT -5
Summary. Afrezza will not be approved for kids in 2017. Probably 2018. . How long until generic afrezza hits the market.
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Post by sportsrancho on Jan 4, 2017 20:25:02 GMT -5
Summary. Afrezza will not be approved for kids in 2017. Probably 2018. . How long until generic afrezza hits the market. I think its 2023 but I believe Bioexec knows?
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Post by brotherm1 on Jan 4, 2017 20:45:36 GMT -5
I recall 2023 also. However I also read biopharma's have been extending their patent expirations more and more frequently. Alteriing/improving the chemical strutures and changing methods of use. The Bluhale patent I suppose would be one way to help keep Afrezza under wraps
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