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Post by mnkdmorelong on Jan 4, 2016 22:43:11 GMT -5
What does SNY have to do to get label improved? What kind of study needs to be done? How long would it take? Could they actually be working on this without us knowing about it? A lot depends on what they are trying to get on the label. FDA trials are public, so no, nothing in secret. The already finished clamp studies might be used to change the label with regard to ketoacidosis, though that seems minor improvement. To get A1c improvement claim would require new trials not yet announced... the type would be a trial with proper protocols for Afrezza with a comparator group on traditional SQ RAA to show Afrezza can lead to lower A1c. Some have speculated that it would take minimum of 2 years for trial and label change. In my opinion trials could be done quicker but I don't have much insight into how long FDA review for a label change might take. It was bought out at the AdCom meeting that Afrezza does not do as good a job as Novolog in HbA1c. If it were not for the statistical "head start" given to Afrezza, the clinical trials would have failed. But this is using Afrezza as you would Novolog. To highlight the real benefit of Afrezza, it must be used differently. The early adopters such as Sam Finta have figured it out and their HbA1c are dropping. Putting this on the label would be beneficial but time consuming as you say. Another route to go is for SNY to sponsor studies by thought leaders using an improved protocol. The better results can be published and that serves as a marketing piece. These clinical trials are not as rigorous as FDA style as there is no monitoring. I had hope that social media would have done some heavy lifting and cause diabetics to demand Afrezza. Sadly, this has not happened in a meaningful way.
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Post by kdaddyfresh2000 on Jan 5, 2016 1:07:42 GMT -5
A lot depends on what they are trying to get on the label. FDA trials are public, so no, nothing in secret. The already finished clamp studies might be used to change the label with regard to ketoacidosis, though that seems minor improvement. To get A1c improvement claim would require new trials not yet announced... the type would be a trial with proper protocols for Afrezza with a comparator group on traditional SQ RAA to show Afrezza can lead to lower A1c. Some have speculated that it would take minimum of 2 years for trial and label change. In my opinion trials could be done quicker but I don't have much insight into how long FDA review for a label change might take. It was bought out at the AdCom meeting that Afrezza does not do as good a job as Novolog in HbA1c. If it were not for the statistical "head start" given to Afrezza, the clinical trials would have failed. But this is using Afrezza as you would Novolog. To highlight the real benefit of Afrezza, it must be used differently. The early adopters such as Sam Finta have figured it out and their HbA1c are dropping. Putting this on the label would be beneficial but time consuming as you say. Another route to go is for SNY to sponsor studies by thought leaders using an improved protocol. The better results can be published and that serves as a marketing piece. These clinical trials are not as rigorous as FDA style as there is no monitoring. I had hope that social media would have done some heavy lifting and cause diabetics to demand Afrezza. Sadly, this has not happened in a meaningful way. I was also hoping social media would explode. Sam and Eric have certainly done their part - above and beyond the call of duty. But that is no excuse for the terrible marketing - can it be called that? - by Sanofi to date. The waste of time due to negligent incompetence or intentional sandbagging (it makes no difference - the result is the same) is tough to stomach.
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Post by silentknight on Jan 5, 2016 6:49:17 GMT -5
I'd say there is a pretty big difference between negligent incompetence and intentional sandbagging.
If they are sandbagging, and all accounts and evidence thus far points to that conclusion for me, then it's grounds for a lawsuit for violating the terms of their partnership for the intentional and deliberate slow roll out of Afrezza for yet undetermined reasons. See Genzyme's lawsuit against SNY for just that reason. It was filed last year.
They have promised to make "commercially reasonable efforts" to launch the drug. With no improvement in scripts, insurance, advertisements, or doctor education, I think it's safe to say their efforts have done little to help Afrezza thus far. I'm of the opinion that the meager sales we've seen to date is due to patient word of mouth and a few endos and GPs that know how effective it is, have figured out proper dosing, are are pushing it to their patients of their own volition. I don't think SNY has done much of anything in the past year and a half to help things along. To the contrary, they've been an obstacle. A truly dedicated partner would have designed and recruited candidates for a superiority study by now, or at a very minimum, expend more efforts into educating prescribers about the drug. They haven't and we're seeing flat scripts week after week. Perhaps I'm impatient, but if you can't even come out in the past year and express your support for the drug publicly, then that tells me a lot.
As we approach year two of the Sanofi experiment, I have to look back at year one. I don't see much to show for it from the partnership. The marketing and launch of Afrezza is SNY's responsibility. If it fails, it's on them. They can and have obtained preferred status for their other drugs in much less time. SNY controlled drugs that have launched after Afrezza have already achieved preferred coverage from insurers. Where there is a will, there is a way. Every week with no growth and no indication that SNY is interested in doing what it takes to ensure success leads me to believe there is no will on their part. I'd love for them to prove me wrong.
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Post by suebeeee1 on Jan 5, 2016 8:07:01 GMT -5
It was bought out at the AdCom meeting that Afrezza does not do as good a job as Novolog in HbA1c. If it were not for the statistical "head start" given to Afrezza, the clinical trials would have failed. But this is using Afrezza as you would Novolog. To highlight the real benefit of Afrezza, it must be used differently. The early adopters such as Sam Finta have figured it out and their HbA1c are dropping. Putting this on the label would be beneficial but time consuming as you say Afrezza is a short acting insulin. From our own experience, learning to use it, we discovered that if you inhaled 15 minutes before a meal, it didn't last long enough to cover the after effects of the meal, even if a small one. But changing the timing was paramount. Using Afrezza after starting a meal made all the difference in the world. The only time it was necessary to take an additional dose was if the meal was very long or filled with excessive carbs. The trials were a straight head to head with Novolog. Administered the same way (too early for Afrezza) and using the same dosage, which we know now is not a one for one conversion. I can't imagine that a head to head matchup now, adjusting for administration differences in timing, wouldn't yield very different results. Perhaps Sanofi needed to wait to start new superiority trials until they were aware of the protocol necessary. They needed to ask the right questions, which the early adopters were able to answer.
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