FDA Approves New Fast-Acting Mealtime Insulin

Officials with the FDA have approved fast-acting insulin aspart (Fiasp, Novo Nordisk) for the treatment of adults with diabetes. Fiasp is a fast-acting mealtime insulin designed for individuals in need of improved overall glucose control.

Fiasp, a formulation of insulin aspart, was developed to more closely match the physiological insulin mealtime response of an individual with diabetes. Vitamin B3 (niacinamide) and a naturally occurring amino acid (L-Arginine) were added to increase the speed of absorption and for stability, respectively.

The approval is based on clinical trials that demonstrated Fiasp’s clinically relevant improvement in long-term glucose level. The trial researchers noted comparable overall rate of severe or blood sugar confirmed hypoglycemia between Fiasp and aspart. The phase 3 clinical program included 4 trials with more than 2100 individuals with type 1 and type 2 diabetes.

According to data presented recently at the 53^rd European Association for the Study of Diabetes Annual Meeting, in the onset 1 trial, Fiasp was compared to conventional insulin aspart in type 1 diabetes over a 52-week study, split in two 26-week treatment periods. Over the 52-week period, Fiasp demonstrated a statistically significant greater overall blood sugar reduction of -0.10% adults with type 1 diabetes, in comparison to conventional insulin aspart. Fiasp also demonstrated a statistically significant reduction in 1-hour post-meal sugar increment of -0.91 mmol/L. However, no significant differences were noted in 2-hour post-meal sugar increment compared with conventional insulin aspart.

Novo Nordisk received a Complete Response Letter (CRL) from the FDA for Fiasp in October 2016, and later resubmitted the new drug application on March 29, 2017.

In this video taken during a satellite symposium held by PTCE in conjunction with APHA2017, Jennifer Goldman, PharmD, discusses the diabetes drug pipeline and the promise it holds for treating patients with type 2 diabetes in the future.

References

Novo Nordisk’s new fast-acting mealtime insulin Fiasp approved in the US [company announcement]. Denmark. http://hugin.info/2013/R/2138112/818474.pdf. Accessed September 29, 2017.

Fiasp significantly improved overall blood sugar control in type 1 diabetes long-term [news release]. Lisbon. Novo Nordisk. https://globenewswire.com/news-release/2017/09/12/1117883/0/en/Fiasp-significantly-improved-overall-blood-sugar-control-in-type-1-diabetes-long-term.html. Accessed September 29, 2017.