The first of the faster insulins that we saw a great deal of detail about at EASD 2016 is due to arrive at wholesalers near us, and it’s imminent. For those who haven’t seen it, take a look at this post detailing the faster insulins. Sadly, in January, Lilly unexpectedly terminated their collaboration with the French company Adocia, on BC Lispro, which had been showing excellent results in the Phase II trials, and it is still unclear why.
The conspiracy theorists might point at Diasome, whose phase IIb trials are being done with Lispro, and therefore, to some extent, likely to be in association with Lilly, given what was said about the Joslin linked IIb trials looking at pharmacist added and manufacturer added HDV. You can’t do the latter without a friendly manufacturer.
Obviously this is just speculation, but the idea of simply adding an accelerator with reduced hypo impact versus having to do a bunch of rDNA manufacturing work to produce your faster insulin would certainly drive me to to look at the economics of one model versus another… We’ll find out later this year, I’m sure!
Back to the topic of FIAsp then. Having called Novo to find out more, they were very willing to tell me plenty. While it doesn’t show the promise that BC Lispro showed, the performance is still better than Aspart (or Novorapid as we know it):
Novo’s trials showed twice as fast absorption, which still looks good, with a similar tail. Reading the prescribing data sheet gives all the data.
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.
The day-to-day variability within-patients in glucose-lowering effect was low for Fiasp both for early (AUCGIR, 0-1h, CV~26%), total (AUCGIR, 0-12h, CV~18%) and maximum glucose–lowering effect (GIRmax, CV~19%).
That tells us that there is a lot more insulin available a lot more quickly. The insulin concentration profile graph also tells us a lot.
Based on the trials data, we’re seeing peak insulin in half an hour, the peak action lasts for about an hour, and an almost instant action time. Oh, and it looks like while the tail is similar in length to Novorapid, the concentration of insulin from one up to three hours is lower. This probably means that slower absorption foods are going to need a bit of extra care to avoid late highs with this stuff.
If you want further details, the linked data sheet has it all.
What about arrival? Well, straight from the Apis Bull’s mouth….
They confirmed that early March was when they’d have it available, and they couldn’t confirm the release date to wholesalers, but the 10th March seems like a reasonable estimate based on the responses to a direct question.
Novo are not replacing Novorapid. FIAsp is a standalone product that will sit alongside Novorapid, although it’s probably worth mentioning that Novorapid is approaching the end of its patent life, so it wouldn’t be a surprise if this were a changeover period by design.
It will need to be ordered by pharmacists through Alliance (as I presume are all Novo products, although I hold my hand up to not knowing about the Novo supply chain), and most importantly, we understand based on consultant feedback, the NHS cost of FIAsp is no different to that of Novorapid!
Whilst Novo are unwilling to confirm this data to a non-Healthcare professional (in spite of me paying for the insulin and the doctor via tax/NI, and all pricing being available on the NHS BSA Drug Tariff website), a quick trip to the aforementioned website shows an interesting anomaly against Insulin Aspart. It no longer has a product name against it for the March 2017 tariff. Formerly it said Novorapid, as per the below picture for February 2017.
And then the corresponding shot from March 2017, which no longer provides a product name. Remember Novorapid and FIAsp are both Insulin Aspart….
If this proves to be incorrect, I’ll update this post…
So there it is. The newest fast acting on the block will be here shortly, and I look forward to getting hold of some and seeing, in the real world, how it compares!