People with diabetes in the United States will soon have access to a new, very fast-acting type of insulin!
Earlier today, news broke that the FDA cleared Novo Nordisk's new insulin called Fiasp, which stands for Faster-Acting Insulin Asparte that's been approved in several countries outside the U.S. over the past year. Novo had initially submitted this a year ago, but the FDA asked for more safety and efficacy data and it was re-submitted for review on March 29 -- meaning it only took six months for approval since.
(This has been a big week for long-awaited FDA diabetes approvals, btw -- with the announcement just days ago of Abbott's FreeStyle Libre Flash Glucose Monitoring system getting a nod too.)
Fiasp is the first injectable fast-acting insulin approved in the U.S. in more than a decade, following Sanofi's Apidra that was OK'd in 2004 (and for kids in 2008); Novo's Novolog in 2000; and Lilly's Humalog in 1996. Of course, MannKind's Afrezza inhaled insulin snagged FDA approval in 2014 and hit the market about two years ago.
"With Fiasp, we've built on the insulin aspart molecule to create a new treatment option to help patients meet their post-meal blood sugar targets," said Dr. Bruce Bode, a well-regarded endo in Atlanta, in a prepared news release. "The intention of rapid-acting insulin therapy is to mimic, as much as possible, the natural physiological insulin response that occurs after meals, a process that is important for optimal A1C management."
Fiasp has drawn quite a bit of interest from the Diabetes Community, because it begins working in just 2.5 minutes and can supposedly be taken 20 minutes after a meal -- something that almost eliminates the concept of "pre-bolusing" that many PWDs struggle with (ourselves included)!
Getting to Know Fiasp
As we reported at DiabetesMine in April 2017, 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.
- Vial and Pen: Novo tells us Fiasp will be available in both a 10mL vial and a FlexTouch insulin pen. However, it is not FDA-cleared for use in insulin pumps, as it is in Europe but not in Canada. Novo does say it plans to request this designation for the US, though.
- Adults Only: This is FDA-approved for adults with both type 1 and type 2 diabetes, but not for the pediatric population at this time. Novo tells us they do plan to seek approval for kids and teens, but it's still TBD on clinical trials and exact timeline. UPDATE: On Jan. 6,. 2020, the FDA granted a label-change allowing Novo's Fiasp to be OK for children.
- Flexible Timing: 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 newer Tresiba basal insulin that can last as long as 42 hours.
- Faster Absorption: It's twice as fast as regular NovoLog or NovoRapid -- 2.5 minutes compared to 5.2, the company states in regard to how quickly it starts working in the bloodstream. The science behind that is apparently two "excipients" that 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 glucose levels and was determined to be just as safe as NovoLog.
- More Hypos?! However, data also showed patients had more hypos in the first two hours after eating a meal -- most likely as the result of unfamiliarity with the quicker action. Yikes!
- A1C Effect: Yes, data also shows that users 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."
Based on what we heard earlier this year from many across the global diabetes community and here among the American DOC (diabetes online community), it appears there's quite a bit of buzz. Early feedback is generally positive, but interestingly some point out that over time they noticed Fiasp wasn't as effective and fast-acting as it had been. Hmmm. We shall see.
Fiasp Availability and Pricing?
A spokesperson on behalf of Novo Nordisk says they hope to launch Fiasp in late December, or by the end of March 2018 latest.
As far as pricing, here's what we're told:
- Fiasp will have "the same list price" as Novolog
- List price for Fiasp will be $275.58 for a 10mL vial and $532.22 for a box of five insulin pens (or $106 per pen, though typically you can't get them individually)
- Novo also notes that Fiasp will be included in "a Savings Card program for eligible patients with commercial insurance to reduce co-pays." It will also be available to eligible patients through the Novo Nordisk Patient Assistance Program. More information on that PAP is available online, as well as by phone at 866-310-7549
By comparison, Fiasp is available in Canada without a prescription for only $30, and many PWDs (especially those in Michigan and Metro Detroit) have been crossing the border to buy it there.
How popular Fiasp will be Stateside is, of course, TBD. And it also brings some exciting possibilities for use in automated insulin delivery and closed loop technology being developed.
We're sending our congrats to Novo on this faster-acting insulin getting approval here in the U.S., though we hope to see some meaningful price reductions on all their insulin products at some point soon. Because really, none of this "insulin innovation" matter much if people can't afford it.