Fiasp approved in Europe

Treatment Insulin
1

Looks like an ultra fast acting insulin has been approved for European and Canadian market…
Interesting, hoping it gets approval in the States (and Switzerland for me, as we are not part of EU market) soon… :slight_smile:

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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.

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My endocrinologist mentioned this recently but said he wasn’t sure how much difference it would actually make. I’m going to ask him about it at my next appointment. I’d like to check it out. Not having to pre-bolus so far in advance for carbs, having temp basal rates kick in faster, and having corrections work faster could all add up to be great.

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WOW - Something new in Canada without waiting for it to be available everywhere else for a few years :slight_smile: I may be taking Fiasp before Tresiba is approved by Health Canada…

I have an Endo appointment next week. Will definitely have to ask about it.

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Interesting. Everyone’s response profile is individual, of course. For me, Apidra is way faster than Novolog/Novorapid. I mean, a lot faster. It will be interesting to see how this compares, once we have access to it.

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Ok - So 101 km/h is faster than 100 km/h…

I am still interested, but don’t see a huge difference. Looks like enough of a difference to to give it a try.

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Images taken from …

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Hmm - how interesting, @AE13. The plasma glucose curves on the OP’s post seem to show a much bigger effect. Based on these curves, I was thinking it would be totally worth it.

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David,
Is it just faster in? Or faster both in and out? The faster out is possibly more valuable to me.

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In my case, both. No guarantees for anyone else.

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I posted the clamp test. The OP had posted a more interesting curve - which is the blood glucose response of a type 1 diabetic to the two insulins. I assume the they gave the test subject some glucose and a shot and then recorded the blood glucose. The good news is that you don’t need to prebolus as much to get the same peak time.

The dissapointment to me is the tail is exactly the same as NovoRapid (novolog) and lasts out to 6 hours. With that said in the 3-4 hour range it drops quicker which makes sense as more insulin is absorbed up front.

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This is what is puzzling me. It is hard to understand that the minor differences in glucose infusion rate in your Fig 2.b explains what seems to be a significant difference in glucose rise in the first 150 minutes (in the OP’s post).

I was also expecting, from the OP’s post, that, since the effect was significantly faster, the larger amount of insulin used up front would mean a thinner/ shorter tail. But, in your Fig 2b, the effect on the tail is hardly noticeable.

As you posted, the gain may be fairly minimal:(

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I am so looking forward to the day they make an injectable that disappears faster. Imagine how awesome that would be, to give your son a decent bolus when he wakes up, knowing it wouldn’t chase him through his morning at school! Or being able to eat later at night and go to bed with no insulin hanging on for hours.

I’ll try Apidra for that reason, when I get some. My Endo said it was only slightly faster, but he’s never actually “used” it like David has! I put a bit more stock in the first-hand user’s account! :relaxed:

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I’m using Apidra right now and really notice no difference between it and Humalog. I’ve never used NovoRapid, but I suspect the timing of that would be identical as well. Even if I could shift a prebolus time by 15 minutes, that would be a reason to switch in my opinion.

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Sounds good! Since we haven’t yet Brexited* I assume it will be available in the UK in 2017. I have a routine clinic appointment on 31 Jan and will ask my Endo if I can try it. Since I use a CGM he will probably be keen to see the results.

Joel

*After Brexit all EU drug approvals go out of the window, so if we are not careful, the only approved insulins will be animal LOL

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And today the Fiasp product monograph got posted to the Canadian Novonordisk website :slight_smile:

http://www.novonordisk.ca/content/dam/Canada/AFFILIATE/www-novonordisk-ca/OurProducts/PDF/fiasp-product-monograph.pdf

Now when will Tresiba be approved in Canada???

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Results of a large Phase 3 (“onset 1”) study of Fiasp versus standard Aspart (Novolog) have recently been reported at 2016 EASD (European Association for the Study of Diabetes) meeting in September last year. The complete presentation is available online. I am copying here just the main results.

  1. Summary of Fiasp versus standard Aspart pharmacodynamics/pharmacokinetics

  2. Postprandial bg increase (in response to a standardized 80 gram liquid meal)

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Based on my own experiences with different insulins I’d not put too much stock in the graphs they publish of it’s duration. I’m sure those are scientifically sound but if I know anything it’s that real life is not a laboratory and results don’t always translate well… that could mean it works Even better than one would suppose too though. I’ll be looking forward to trying it.

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The old YDMV comes into play big time on this! Like Apidra - some find it very quick, some find it the same as the others. for some, it doesn’t work well at all – and everything in between. I will be looking forward to trying it, though.

From what I’ve seen on Novo’s R&D site (some time back) Fiasp is only one of two faster analogs they have (had?) in development - and I believe the other one is the even faster version. Probably will be a while (if ever) until we see it, though.

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It could be a long time. Look how long Linjeta has been in the works! Ha!

I think a lot of the new ones are being developed to have enzymes or molecules added, things like EDTA or hyaluronidase, rather than just restructuring the insulin molecule. Not sure, but maybe that takes even longer to get approval.

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Do we know when this baby will hit the markets in the EU? I would love to see a faster acting insulin in my pump after using Humalog for more than 20 years.

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AFAIK it is already approved in Germany or about to be approved.

From what my endo told me, however, the differences are expected to be marginal, I don’t know if we will even be able to tell the difference in everyday use.
but looking forward to reports from anyone who has worked with it.