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Post by mnholdem on Sept 18, 2017 15:55:11 GMT -5
Having posted that I recalled having read...
I checked the EMA and they have NOT created a new classification for Fiasp. Inside, the designation came from a Novo press release:
January 10, 2017 08:18 ET | Source: Novo Nordisk A/S
multilang-release
Bagsværd, Denmark, 10 January 2017 - Novo Nordisk today announced that the European Commission has granted marketing authorisation for Fiasp® for the treatment of diabetes in adults. The authorisation covers all 28 European Union member states.
Fiasp® is the brand name for fast-acting insulin aspart. Fiasp® provides improved mealtime and overall glucose control with a similar safety profile versus NovoRapid®.
"Fiasp® is a new-generation mealtime insulin; it is an innovative faster formulation of insulin aspart that more closely mimics the physiological insulin response around meals. The incremental benefits with Fiasp® are comparable to those observed for the last generation of mealtime insulins when introduced more than a decade ago", said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
Fiasp® will be available in vial, Penfill® and FlexTouch® pen.
Novo Nordisk expects to launch Fiasp® in the first European countries in the first half of 2017.
About Fiasp®
Fiasp® (fast-acting insulin aspart) is an ultra-fast rapid-acting insulin now approved in Europe that improves control of postprandial glucose (PPG) excursions and has been developed for the treatment of people with type 1 and type 2 diabetes, as well as for pump treatment.
Fiasp® is insulin aspart (NovoRapid®) in a new formulation, in which two new excipients have been added to ensure earlier, greater and faster absorption, thereby providing earlier insulin action. The review of Fiasp® was based on the onset programme, a phase 3 clinical programme comprising of four trials encompassing more than 2,100 people with type 1 and type 2 diabetes.
Fiasp® also received marketing authorisation from Health Canada on 6 January 2017, and has been filed for regulatory review in the US, Switzerland, Australia, Canada, Brazil, South Africa and Argentina.
Source: globenewswire.com/news-release/2017/01/10/904755/0/en/Fiasp-fast-acting-insulin-aspart-approved-in-Europe.html
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Novo Nordisk's use of the term was/is merely descriptive...a marketing ploy. The EMA has not created a new classification of insulin for Fiasp.
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Post by mango on Sept 18, 2017 15:59:47 GMT -5
mango "Would the FDA not declare the distinction between ultra-rapid and fast-acting if the new class is made?" Don't think I'd venture a guess on that one. My crystal ball is out at the shop for its annual polishing and tuning. If the FDA channel is working on it when I get it back, I think I can make a fortune predicting what the FDA will do. I could definitely see the new FDA Commissioner on board. This is simple stuff. No insulin has a peak serum concentration within the required physiological time frame other than Afrezza. It's a night and day comparison. When you look at the speed of Afrezza you quickly realize it's peak serum concentration is well within the natural endogenous time frame and every single insulin besides Afrezza is not. That's why it is so successful in restoring glucose homeostasis. First phase insulin secrection is extremely important and any PWD that is not using Afrezza does not have a first phase insulin response nor an efficient second phase insulin response. This is needed to help restore balance and work in synch with the rising blood glucose. |
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Post by zuegirdor on Sept 18, 2017 16:05:13 GMT -5
There is currently a new class according to a market research document: "ultra short acting insulin" and this can only be in prelude of an announcement because the performance is known already in the elite diabetes circle. Fiasp has recently received the EMEA designation "Rapid-acting insulin" and seeking for fast acting insulin from the FDA. Afrezza is ultra short acting insulin according to data collected during a study pd/pk fast in fast out ALMOST like a healthy pancreas The criteria for this designation should not be the issue since the benchmark this this time will be a healthy pancreas and we have CGM already approved as medical device for data collection. Now let the FDA talk mannkind future !! "Ultra short acting". That is kind of a back-handed jab at the Ultra Rapid claim we thought would be sought, NO? I mean, gets at why Afrezza is superior for hypos; but Short and Rapid are apples and oranges. Most people won't get what it means for hypos. I wonder if this was what Mannkind asked for? Ultra Rapid and ultra short acting might work. but its go to be both. Short acting alone sounds like a deficiency, not at all of reflective of the AFrezza PK/PD. hogwash. |
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Post by madog365 on Sept 18, 2017 16:14:30 GMT -5
One and only true ultra-rapid acting insulin is Afrezza. Fiasp calls themselves Ultra-Fast Rapid-Acting, which to me is just a marketing play on words/gimmick. www.rnceus.com/dmeds/types.htm |
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Post by peppy on Sept 18, 2017 16:27:59 GMT -5
Fiasp
Pharmacodynamic effects
Fiasp is a mealtime insulin aspart formulation in which the addition of nicotinamide (vitamin B3) results in a faster initial absorption of insulin compared to NovoRapid.
The onset of action was 5 minutes earlier and time to maximum glucose infusion rate was 11 minutes earlier with Fiasp than with NovoRapid. The maximum glucose-lowering effect of Fiasp occurred between 1 and 3 hours after injection. The glucose–lowering effect during the first 30 minutes (AUCGIR, 0–30 min ) was 51 mg/kg with Fiasp and 29 mg/kg with NovoRapid (Fiasp/NovoRapid ratio: 1.74 [1.47;2.10]95% CI). The total glucose–lowering effect and maximum (GIRmax) glucose–lowering effect were comparable between Fiasp and NovoRapid. Total and maximum glucose–lowering effect of Fiasp increase linearly with increasing dose within the therapeutic dose range.
The duration of action was shorter for Fiasp compared to that of NovoRapid, and lasts for 3–5 hours. (notice the label does not say, how much shorter.) www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004046/WC500220890.pdf
Fiasp administered at mealtime was non-inferior to NovoRapid in reducing HbA1c, and the improvement in HbA1c was statistically significant in favour of Fiasp.
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Post by mango on Sept 18, 2017 16:36:24 GMT -5
One and only true ultra-rapid acting insulin is Afrezza. Fiasp calls themselves Ultra-Fast Rapid-Acting, which to me is just a marketing play on words/gimmick. www.rnceus.com/dmeds/types.htmNovo Nordisk is very familiar with how to be unethical and corrupt. Ultra fast rapid acting is exactly what you said, a play on words and a total gimmick. maybe the new insulin class should have very specific defining characteristics that are logical and common sense-like. Diabetes renders the beta cells from functioning properly, throwing glucose homeostasis out of balance. First phase insulin secretion doesn't exist in PWD via beta cell failure and has been effectively rendered from its role in maintaining glucose homeostasis. Afrezza displays the first and second phase insulin responses that mimics the endogenous signaling processes like that of a healthy nondiabetic pancreas in homeostasis. The description should mirror what Afrezza literally does, restores balance. Mimicking the endogenous prandial insulin secrection, restoring the human first and second phase insulin responses with a high potential at bringing the body back into glucose homeostasis and maintain it there. When you are mimicking natural signaling pocesses like this that a normal healthy functioning body does, you are effectively restoring health. Injectable insulin companies suppress this kind of information from the public, never talks about, obviously has hindered the Endo communities' ability to understand these simple concepts by involving the decision makers and thought leaders into their world. It's that simple. |
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Post by peppy on Sept 18, 2017 17:44:08 GMT -5
*Insulin aspart is produced in Saccharomyces cerevisiae by recombinant DNA technology.
HUMALOG
Humalog (insulin lispro injection, USP [rDNA origin]) for injection
Insulin lispro is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli.
Just looking, they are produced by different bacteria strains.
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Post by mango on Sept 18, 2017 18:05:29 GMT -5
*Insulin aspart is produced in Saccharomyces cerevisiae by recombinant DNA technology.
HUMALOG
Humalog (insulin lispro injection, USP [rDNA origin]) for injection
Insulin lispro is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli.
Just looking, they are produced by different bacteria strains.
Heh. • As a single-cell organism, S. cerevisiae is small with a short generation time (doubling time 1.25–2 hours[21] at 30 °C or 86 °F) and can be easily cultured. These are all positive characteristics in that they allow for the swift production and maintenance of multiple specimen lines at low cost.
• Also used for studying space and preparation of future deep space missions: Among other microorganisms, a sample of living S. cerevisiae was included in the Living Interplanetary Flight Experiment, which would have completed a three-year interplanetary round-trip in a small capsule aboard the Russian Fobos-Grunt spacecraft, launched in late 2011...Fobos-Grunt's mission ended unsuccessfully, however, when it failed to escape low Earth orbit. The spacecraft along with its instruments fell into the Pacific Ocean in an uncontrolled re-entry on January 15, 2012.Reply: sounds like a smart organism. Capable of mutations for adapting? |
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Post by mnholdem on Sept 18, 2017 19:12:55 GMT -5
One and only true ultra-rapid acting insulin is Afrezza. Fiasp calls themselves Ultra-Fast Rapid-Acting, which to me is just a marketing play on words/gimmick. www.rnceus.com/dmeds/types.htmNovo Nordisk is very familiar with how to be unethical and corrupt. Ultra fast rapid acting is exactly what you said, a play on words and a total gimmick. Drug companies aren't permitted to market in the European Union or Canada and Novo Nordisk won't be able to market the phrase "ultra rapid-acting" in the U.S. when Fiasp gets approved by the FDA. They are simply exaggerating in these PRs, the strategy being to try to build curiosity/interest among KOLs in the U.S. All the giant BPs do it and sometimes they get fined by the FDA when they cross the line too far. It seldom seems to deter them, though. |
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Post by mango on Sept 18, 2017 19:18:48 GMT -5
Novo Nordisk is very familiar with how to be unethical and corrupt. Ultra fast rapid acting is exactly what you said, a play on words and a total gimmick. Drug companies aren't permitted to market in the European Union or Canada and Novo Nordisk won't be able to market the phrase "ultra rapid-acting" in the U.S. when Fiasp gets approved by the FDA. They are simply exaggerating in these PRs, the strategy being to try to build curiosity/interest among KOLs in the U.S. All the giant BPs do it and sometimes they get fined by the FDA when they cross the line too far. It seldom seems to deter them, though. It's crazy. They didn't even call it that in their studies or in their recent presentations they posted on Twitter. They are trying to rip off Afrezza. They know what's coming and they are scared chitless |
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Post by agedhippie on Sept 18, 2017 19:35:31 GMT -5
Drug companies aren't permitted to market in the European Union or Canada and Novo Nordisk won't be able to market the phrase "ultra rapid-acting" in the U.S. when Fiasp gets approved by the FDA. They are simply exaggerating in these PRs, the strategy being to try to build curiosity/interest among KOLs in the U.S. All the giant BPs do it and sometimes they get fined by the FDA when they cross the line too far. It seldom seems to deter them, though. It's crazy. They didn't even call it that in their studies or in their recent presentations they posted on Twitter. They are trying to rip off Afrezza. They know what's coming and they are scared chitless. They are far more concerned with differentiating themselves from the other insulins. They got burnt with Tresiba and they want to avoid the same fate again. To an extent they have learnt their lesson and Fiasp is being priced the same as Novolog (Tresiba was more expensive than Levemir, the insulin it was replacing). |
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Post by tchalaa on Sept 19, 2017 1:30:18 GMT -5
NVO
- Fast-acting insulin aspart
Type 1 and type 2 diabetes
PDUFA 09/29/2017
NDA filing resubmission noted March 29, 2017 in response to CRL issued October 2016. Estimated latest possible PDUFA date - September 29, 2017 using 6-month timeline. Waiting for official date from company.
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Post by sayhey24 on Sept 19, 2017 5:36:18 GMT -5
It's crazy. They didn't even call it that in their studies or in their recent presentations they posted on Twitter. They are trying to rip off Afrezza. They know what's coming and they are scared chitless. They are far more concerned with differentiating themselves from the other insulins. They got burnt with Tresiba and they want to avoid the same fate again. To an extent they have learnt their lesson and Fiasp is being priced the same as Novolog (Tresiba was more expensive than Levemir, the insulin it was replacing). IMO, they should be concerned. There are lots of complaints about injection site issues and as Gary Sheiner says when comparing speed, its no afrezza. integrateddiabetes.com/blog/Speed and repeatability is critical when developing time in range and dosing algorithms. I see Accenture is even in the monitoring game now. Maybe Lifelock can get in too and address the problem. newsroom.accenture.com/news/accenture-to-transform-diabetic-patient-care-using-data-driven-analytics-platform.htm |
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Post by agedhippie on Sept 19, 2017 7:48:55 GMT -5
They are far more concerned with differentiating themselves from the other insulins. They got burnt with Tresiba and they want to avoid the same fate again. To an extent they have learnt their lesson and Fiasp is being priced the same as Novolog (Tresiba was more expensive than Levemir, the insulin it was replacing). IMO, they should be concerned. There are lots of complaints about injection site issues and as Gary Sheiner says when comparing speed, its no afrezza. integrateddiabetes.com/blog/Speed and repeatability is critical when developing time in range and dosing algorithms. I see Accenture is even in the monitoring game now. Maybe Lifelock can get in too and address the problem. newsroom.accenture.com/news/accenture-to-transform-diabetic-patient-care-using-data-driven-analytics-platform.htmWhile they should be concerned down the road right now there is a far bigger problem for insulin manufacturers and that is expiring patents. This opens the way to biosimilars and competitiion. Sanofi didn't come up with Toujeo because they needed a better basal, they came up with it because the Lantus patent expired and they needed to protect their sales with a new patent. Likewise Sanofi didn't develop their Humalog biosimilar because Humalog is a wonderful insulin, they did it to grab sales from Eli Lilly. From Novo Nordisk's point of view Afrezza is a hypothetical threat as two and a half years after launch Afrezza's market share is a rounding error in Novolog sales. We know there are reasons for this, but they look at the sales. Patent expiry and biosimilars on the other hand is an immediate and tangible threat, and that is what keeps them up at night. |
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Post by joeypotsandpans on Sept 19, 2017 8:55:57 GMT -5
If you think this is just a timing coincidence think again. Novo knew what they stood to lose if Afrezza were to get its due. They bought (in many ways including the shorting of MNKD) themselves the two plus years to get to this point as they are trying to share the new category so they can undercut pricing like they did with Levemir to Lantus for the insurance edge. We're at the finish line, the category is one thing the enhancements to the label are another regarding what claims can be made. Label is everything IMO to opening the insurance gate in turn unleashing scripts from a broader acceptance of physicians, etc. The sales teams will feel like they had shackles removed. Backlog of scripts will also be freed up, like the one I received and never was filled due to insurance despite two prior authorization attempts, there are many awaiting the revised label. The "needle" on the scripts number will move big time...pun intended  |
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