There's a new ultra fast-acting insulin on the market internationally, and hopefully before long it will become available to us here in the U.S. too.
You may have heard mention of FIASP, or Faster-Acting Insulin Aspart, that recently hit the market overseas and in Canada -- and been wondering what the deal is with this new super-fasting insulin. We put our ears to the ground to learn more about it, what PWDs (people with diabetes) who've started on this med are saying online, as well as what its manufacturer Novo Nordisk has to say about this new product that was just recently re-submitted to the FDA for consideration as a new type of medication.
Here's what we've heard:
Getting to Know FIASP
What exactly is Faster-Acting Insulin Aspart? Remember, insulin aspart is the official scientific name for the synthetic insulin analog that sells under the brand Novolog here in the States and NovoRapid internationally.
- What's in a Name? OK, so maybe FIASP is not the most creative branding (sounds like a variety of wasps?), but the name certainly fits. Whether it will carry a new brand name here States when launched remains TBD.
- By Vial or Pen? Internationally, FIASP is available by vial, Penfill, and FlexTouch insulin pen. Interestingly, we see that in Europe it's approved for insulin pumps but it's not pump-approved in Canada. Hmm. Here in the U.S., Novo tells us FIASP will only be available in pen form.
- Timing Flexibility: FIASP can be taken anywhere from 2 minutes before a meal or up to 20 minutes after the start of a meal, and apparently works just as well as NovoRapid/NovoLog that is taken before mealtime. While Novo officially still recommends taking FIASP before the meal, overall they're touting more flexible dosing, mentioning “earlier, greater and faster absorption, thereby providing earlier insulin action." This something that Novo has also pushed with its new Tresiba basal insulin that can last as long as 42 hours.
- Faster Absorption: It's twice as fast as regular NovoLog or NovoRapid. Getting into the science, that's because two "excipients" have been added to FIASP’s formulation -- Vitamin B3 (niacinamide) to increase the speed of absorption, and a naturally occurring Amino Acid (L-Arginine) for stability.
- Better Post-Meal BGs: Clinical trial data in which more than 2,000 PWDs with type 1 and type 2 were tested using FIASP showed the new insulin was linked to a lower spike in post-meal BGs and was determined to be just as safe as NovoLog.
- More Hypos?! However, data also shows patients had more hypos in the first two hours after eating a meal -- most likely, as the result of not being used to the quicker action.
- A1C Effect: Yes, data also show that patients lowered their A1C levels. This remains important, despite the fact that PWDs have been saying for years (and the FDA has recently acknowledged) that A1C is not the end-all, be-all guage for diabetes care. So it will be interesting to watch how FIASP proves itself with other measures like time in range.
The FDA actually sidelined FIASP in Fall 2016, asking the company for more detailed information about the "assay for the immunogenicity and clinical pharmacology data." On March 29, Novo just re-submitted their FDA application for review, so it's TBD how quickly it moves from there. The company expects to hear back from regulators by year's end.
Real-Life Feedback on FIASP
How are patients liking FIASP? It's pretty early to tell still. And of course "fast-acting" is often a subjective term just like everything else in this pancreatically-challenged universe of ours; Your Diabetes May Vary.
One of the best visual explanations we've seen on FIASP to date comes from diabetes nurse specialist in London, UK, Ines Parro, who created this infographic for her informational site Daybetes:
And here's a sampling of some of the online feedback we've seen around the global Diabetes Online Community (shared with their permission, where applicable):
"I have been using FIASP for 30 days. I was using NovoRapid/NovoLog before. FIASP doses the same for me. I find that it starts to work faster than NovoRapid and it stops working a little faster as well around the 3-hour mark. It is too early to see results in my A1C. I did find some injection site discomfort the first few days, nothing serious. That has subsided now and I don't feel a thing with a bolus. I have tight control, 5.8% A1C last time. I think it will make a difference as I can stop a rising high post-meal BG much more effectively than with NovoRapid. I do notice that when I bolus there is a sensation similar to what I felt when injecting Lantus before I switched to the pump."
-- Steve, a Canadian in an OmniPod group on Facebook, who also mentions that insulin is available over the counter in his country.
"Have been on FIASP for a week now, and holy smokes -- what a difference that has made for my blood sugars and overall control. I barely have words to describe my gratitude. For my fellow pancreatically-challenged friends, cannot say enough about how much this has helped with meal-time dosing and corrections. Game-changer!! #fiasp #gamechanger #insulin"
- Sandy Struss in Canada
"Someone who has tried it said the initial drop is fast, so make sure you are eating and the tail is shorter... so far she likes it but she is also using it with a closed loop system."
-- from the Women with Diabetes group on Facebook
"I've got some in my Omnipod right now. I don't find it works any faster or shorter acting than the Apidra that I had been using before (but Apidra was a lot faster and shorter-acting for me than Humalog and Novolog). What it did do though, was drop my BG way more than I expected, so I guess it is more effective. My very first meal with it I bolused the same 4 units that I normally would for the lunch I eat everyday, and my BG fell to 2.9 mmol/L (52 mg/dl) around 90 minutes after eating, where as normally, from the 6.5 I started at, Apidra or Humalog would have brought be down to 5.5 or 6.0 after eating. I've had to lower my basal rate as well, because I woke up three times last night to the low alarm from my Dexcom. I am using fewer units per day, but I find its effects less predictable than Apidra for me. There is probably going to be a descent length adjustment period to learn the idiosyncrasies of it."
- Vicka Plume in Canada, as posted on the TuDiabetes forums
We're also following our UK D-friend Tim Street over at DiabetTech, who's been experimenting and chronicling his FIASP experience since starting on it in March -- from his first 48 hours and initial impressions, to wondering if "this is, in fact, the next-gen insulin we've been waiting for?" He was initially enthusiastic, but ran into some snags later, as noted in his latest Further FIASP Insight blog post:
"At first it was a joy, with massively reduced bolusing time and huge efficiencies, however as the month has progressed, our friendship has soured somewhat. I’ve been needing more and more of it and it’s not been much fun trying to work out what’s been going on."
Specifically, Tim notes that while FIASP appears to work faster, it has also increased his insulin sensitivity and he's observing that it seems less effective per unit as time goes on. He wonders whether that could be a long-term issue for this product across the board, or maybe just an effect personal to him.
He also notes: "For meals with a slow absorption profile, there is a real risk of hypoing here if the upfront bolus is too high. It looks like it will be beneficial in the use of a square wave or dual wave/combi bolus though. I think these factors will need to be considered in changing to this insulin. People may need to re-learn their bolusing strategy dependent on the foods that they eat. Something for both PWDs and HCPs to be aware of when looking at changing."
We're happy to see Tim inviting others from around the D-Community to share their own experiences with FIASP, to help everyone better understand how it works in real life. Great idea, Tim!
Access and Affordability?
Of course, any new insulin product these days brings critical questions of access and affordability.
No matter how great the innovation, it doesn't much matter if people can't afford it or get access through their insurance plans. So what's the status of cost and coverage for FIASP?
We're told that in the EU and Canada, FIASP carries the same cost as existing Novolog insulin, whereas U.S. pricing has not yet been finalized, according to Novo.
That's a little unnerving given the complicated drug pricing and insurance coverage system we're faced with here in the States, where insurance plans have no real incentive to let patients change to newer or different medication varieties if they cost more. In fact, the payers are notoriously pushing patients to cheaper alternatives these days (i.e. non-medical switching), which gave birth to the #PrescriberPrevails advocacy campaign calling for physicians (and patients) to have the freedom to select the best treatment for the individual.
At the moment, we can only cross our fingers that PWDs will have reasonable access to any insulin they need, up to and including exciting faster-acting varieties that could improve results.