Faster-Acting Insulin Aspart (Fiasp) Resubmitted to the FDA

By Ava Runge

A decision on Novo Nordisk’s faster-acting mealtime insulin is expected in late 2017; also launched in Canada, Germany, and the UK, and coming soon to more European countries

Novo Nordisk recently announced that it has resubmitted its new, faster-acting mealtime insulin (“faster-acting insulin aspart” or “Fiasp”) to the FDA, with a decision expected toward the end of 2017. This is the second time Novo Nordisk has submitted Fiasp to the FDA for approval – the FDA requested further safety information about the drug after it was submitted the first time last fall. Based on the announcement, it seems that Novo Nordisk has gathered the additional data to address these concerns and given it to the FDA.

Fiasp is already available outside the US, having launched in Canada last month, and even more recently in Germany and the UK. The next-generation mealtime insulin was also approved in January in Europe, and should launch in other EU countries later this year. Furthermore, it was recently approved in Norway and Iceland, and is under review in Switzerland, Australia, Brazil, South Africa, Argentina, and Israel. diaTribe is looking forward to hearing about experiences with Fiasp as it becomes available in many of these countries. Fiasp is the first-ever next-generation mealtime insulin to launch globally, as MannKind’s inhaled insulin Afrezza is only available in the US.

Fiasp’s global progress is a very positive sign for insulin users, particularly those looking to improve their mealtime blood sugars. The new insulin has a faster onset and offset than NovoLog, meaning it should better control initial post-meal spikes in blood sugar and cause less hypoglycemia hours later. This also brings a convenience and flexibility win: Fiasp taken 20 minutes after the start of a meal has been shown to manage blood glucose levels as well as NovoRapid/NovoLog taken just before mealtime. Compared to those using NovoRapid, Fiasp users also saw slight A1c improvements in several studies, without a higher likelihood of severe hypoglycemia. Blood glucose levels an hour after mealtime averaged also about 10 mg/dl lower in people taking Fiasp than in those taking NovoRapid. We would love to see trials done with Fiasp where “time in zone” numbers are shown, meaning time in hypoglycemia, time in-range, and time in hyperglycemia.

While the FDA regulatory process differs from international regulatory processes, we hope that Fiasp’s approval in Canada and in European countries will bode well for the drug’s future in the US. If approved, it is also expected that Fiasp could be rapidly included in automated insulin delivery studies, since faster insulin could enable better automated control after meals. diaTribe hopes that access to Fiasp will be positive in the US as well as internationally.