Fiasp, a new, faster-acting insulin from Novo Nordisk, is generating a lot of interest and carries with it much potential for improved diabetes care. A sort of acronym for faster acting insulin asparte, Fiasp starts working within two minutes of injection and can even be effective in lowering blood sugar when taken up to 20 minutes after a meal. Existing fast-acting insulin formulations such as Humalog, Apidra and Novo Nordisk’s own NovoLog (called NovoRapid in Europe and Canada), take 10 to 20 minutes to begin lowering blood sugar after injection.
According to Novo Nordisk, Fiasp, “has its maximum effect between 1 and 3 hours after the injection and the effect lasts for 3 to 5 hours.”
“Our goal in developing Fisap was to try and get closer to mimicking the body’s own insulin response to food,” says Michael Bachner, Associate Director for Product Communications for Novo Nordisk. “Doing that creates a lot of opportunities for how this might be applied to improve care.”
Fiasp was approved for use in Europe in January and approved in Canada in late March. Approval in the United States is pending with Novo Nordisk expecting to hear back form the FDA in the fourth quarter of this year, Bachner says. (The FDA application is the Danish pharmacy giant’s second attempt at U.S. approval.)
Interest in the new insulin is keen, according to chat boards and as reported by Mike Hoskins for the DiabetesMine team in late April. Tim Street, a diabetes writer, reports an uptick in views to his site since he started reporting on Fiasp. His website diabettech.com—“Where diabetes and technology meet”—says when he started writing about Fiasp visits to his site went from between 200 and 500 per day to between 500 and 1,000 per day. To date, Street has penned six articles about the new insulin.
“It’s generated a lot of interest because it holds a lot of promise,” Street says. “The faster onset could certainly cut postprandial spikes in blood glucose levels.”
Street put Fiasp to an interesting and unique test to find out whether the new insulin actually, or only theoretically, worked within two minutes of injection, as well as to test its peak and drop times.
Street pitted a 4.7 unit dose of Fiasp against one Krispy Kreme doughnut, which was a force to be reckoned with at 47 grams of carbohydrate. Street did his bolus of Fiasp 10 minutes before he downed the doughnut. The result, according to Street, was in line with what Novo Nordisk said about how the insulin behaved in clinical trials.
Two exceptions, according to Street, who holds an engineering degree, appear to be that doses taken together or quickly one after the other might cause hypoglycemic reactions and Fiasp does not appear to prevent postprandial high blood sugars if a lot of carbs are eaten. However, he admits more research is needed and that his tests were fairly anecdotal.
“But the biggest question, by far, is whether or not it’s truly faster?” Street said. “My initial cautious response to that is, yes. It seems to be.”
That speed in effectiveness is key to making Fiasp a potential blockbuster drug for several reasons. For Street, Bachner’s comment that Novo Nordisk aimed to create insulin that acts as similar to human insulin as possible makes it a perfect candidate for being the fuel that an artificial pancreas can most effectively run on.
“Novo Nordisk is very interested in expanding the use of fast-acting insulin aspart in an artificial pancreas setting,” Bachner says, although he was unable to provide details regarding those plans. “While Fiasp is approved for use in insulin pumps in Europe, it is not yet approved for use in pumps in Canada.” He says additional trials are needed to gain approval for that use.
Whether or not Fiasp becomes the first choice of insulin for use in an artificial pancreas, or pumps, is almost beside the point. Fiasp is poised to potentially become the overall leader in the enormous market segment of fast acting insulin.
NovoLog, which was launched in 2000 in Europe and 1999 in the U.S., has carved out and maintained a significant segment of the insulin market. It was the third best selling diabetes medication in 2015 with $3.03 billion in global sales, according to the pharmaceutical industry tracking website pharmaceutical-technology.com. However, Fiasp won’t only be competing with segment leader NovoLog. Fast acting insulin Humalog, from Eli Lilly, was right behind NovoLog with $2.84 billion sales that same year, meaning that Fiasp could become a blockbuster not only by replacing its related insulin NovoLog, but by also overtaking Humalog.
Bachner cautions that sales data are not available to see how Fiasp is selling since it hit the market so recently. He also says that the price point for Fiasp in Canada and Europe is on parity with NovoRapid. Whether the price will be on the same scale with NovoLog in the U.S. when Fiasp is introduced has not yet been determined.
“I’m not sure if there is a willingness to pay a premium for new drugs,” Bachner says. “But, so much with Fiasp is so new that it’s still a wait and see game regarding almost every aspect of it.”