FDA Approved Fiasp


#1

(Reuters) - The U.S. Food and Drug Administration on Friday approved Novo Nordisk’s fast-acting insulin to treat diabetes.

The product, known as Fiasp, is designed to help diabetics control post-meal spikes in blood sugar. It is already approved in Canada and Europe.

Fiasp, or faster acting insulin asparte, is designed to work faster than existing fast-acting insulin such as Eli Lilly and Co’s Humalog and Novo Nordisk’s own NovoLog, known as NovoRapid outside the United States.

Last year the FDA declined to approve the product and requested additional information.

Reporting by Toni Clarke in Washington; Editing by Chizu Nomiyama


#2

This makes one more piece of good news for people with diabetes in the US. Also announced this week was the FDA approval of Libre, the flash glucose monitor. While I am almost always impatient for these products to appear here, especially ones introduced elsewhere in the world, I’m glad the FDA is performing their job.

I am interested in trying Fiasp but I’ve shown pump site allergy symptoms to Novolog in the the past. I’ve read several accounts of Fiasp users in Europe complaining of pump site swelling. Maybe I could make good use of it as an occasional syringe delivered correction. I will try to get a sample from my doctor’s office and experiment.

The pace of introducing new D-tech into the US seems to be picking up, or is that just me?


#3

This is exciting! Thanks for posting this, @tiaE!!


#4

Is it th time of year? I remember announcements this time last year as well (Libre Pro and 670G).


#5

That’s a good idea, and though I no longer use Fiasp in my pump, I’ve hung on to a vial just for this purpose (that is, until Afrezza arrives in Canada). That said, my own experience was that Fiasp did not have significantly faster onset than Humalog (in my reading online, it turns out to be about 10 minutes faster), did not have a significantly earlier peak, and had a duration about the same, which kind of mitigates its usefulness for corrections. Others’ experiences will no doubt differ, as always.


#6

Curious how long before insurance will cover?CVS/caremark.


#7

I am persuaded by this graph published by the European Medicines Agency.

Note the considerable amount of “area under the curve” difference between the early solid Fiasp line and the dashed Novolog line. While the time of onset and peak are not too much different, it does add up to a significant cumulative effect in the first 45 minutes.


#8

Additional info:

Pricing the same as Novolog.

Approved for 18+.


#9

I’m excited as well. Now to find out if my daughter’s insurance will cover it.


#10

I had the same experience. It was not anything amazing. Maybe a little faster, not much.


#11

It’s amazingly great. My DD uses it. She takes it with meals, lasts 3 hours, beautiful, gradual drops - no double arrows down. Works far faster than novorapid for her.


#12

I’m hearing on-line reports of bolus amount change with fiasp. The bolus needing to be much larger but the basal not changing. And the bolus amount increases over time. And a suggestion that a 50/50 mix with humalog works well. Individual posts. Time and experience will tell. Note: I’ve been disapointed with recent drug advances.


#13

Wonder how long until the VA will provide this?
I often have a hard time pre bolusing for meals with me hectic job. This could be a big game changer for me.


#14

The reports I have heard from actual users seem to differ “slightly” from the marketing propaganda. Although as always, I am sure it works better for some then for others.


#15

Oh I understand that it has a pretty wide range of affects for different people. I’m in sales and do not have any set time frame to eat anything. So any chance for this to keep me safer on how, or when I dose, all the better.
I also think, based on reports, is that I will need to square wave bolus to acommadete for carbs, then later for protein /fat.


#16

We use this feature also (Extended Bolus for us - pretty sure exact same concept) and probably should make greater use of it. It is easy to get lazy and just hit the (regular - immediate) bolus without thinking of the Square/Extend/Combo option for Bolus but based on the content of the meal (as you say, more protein/fat) then it really is worth the minor extra effort.


#17

Other pumps offer the square wave. The X2 only does the extended.
BUT, you can easily cheat and enter a second bolus, only do a 5% now and 95% later. Just enter what you think the protein/fat bolus would be for the second bolus (LOT easier than trying to split the initial bolus and have carbs for now and protein/fat for the extended.)


#18

@Hammer - I must have been confused on the terminology. I thought the square and the extended were the same but just different words for the different pumps.

What is the difference between a square bolus and an extended bolus?


#19

A combination bolus (part of the dose now, the rest delivered over time) is called Multiwave on Accu-Chek, Combo on Animas, and Dual Wave on Medtronics.

An extended bolus (all the dose delivered evenly over a specified period) is called Extended on the Accu-Chek and Animas, and Square Wave on Medtronic.

Both options are available on the Omnipod under “Extended.”

That’s as of spring 2016.

The trick, of course, is judging how much the protein and fat will raise you later, and when, and how much of your dose you should therefore extend.


#20

Yeah, entering it all at once seems like a more difficult solution.
I am saying that I will do one bolus for the carbs, then a second separate bolus, using the 5/95% extended for protein/fat.
It is a LOT easier to do the math this way.
I use the 50% protein and 10% fat rule. Not perfect, but pretty darn close.