Fast-Acting Insulin Aspart for Mealtime Gains FDA Approval

Novo Nordisk announced that the FDA has approved its insulin aspart injection Fiasp, which can rapidly improve glycemic control at mealtimes for patients with type 1 and type 2 diabetes.

According to a press release from Novo, the new injection is similar to the fast-acting insulin aspart NovoLog, but also contains niacinamide, known as vitamin B3, which helps the body absorb insulin faster. "According to an analysis in our FDA submission, Fiasp appeared in the bloodstream in 2.5 minutes. In that same analysis, NovoLog appeared in the bloodstream in 5.2 minutes. Due to its fast onset and appearance in the bloodstream, Fiaspcan be dosed at the beginning of a mealtime or within 20 minutes after the start of a meal," Todd Hobbs, MD, chief medical officer for diabetes, Novo Nordisk North America.

Similar to NovoLog, Fiasp will be sold in both 10 mL vials and in prefilled delivery pens marketed as FlexTouch by Novo. It will also have an identical list price to NovoLog, and the press release indicates that it will be eligible for the manufacturer’s Savings Card and Patient Assistance Program.

While the original insulin aspart is meant to be fast-acting, the new Fiasp with the addition of niacinamide will help the drug act even more quickly. This speed is especially important during meals, which can lead to blood sugar fluctuations that make it difficult for people with both types of diabetes to achieve optimal blood glucose levels. Fiasp may be used at the start of a meal or within 20 minutes of when the patient starts eating.

The FDA approved Fiasp based on positive results from the Onset clinical trial program, which enrolled over 2000 adults with type 1 and type 2 diabetes. In phase 2a of the trial, patients with both types had a reduction in A1C levels after taking Fiasp, whether it was administered at mealtime or after they had started a meal. Trial participants reported some adverse reactions, including nasopharyngitis, upper respiratory tract infection, nausea, diarrhea, and back pain. Fiasp is not approved for children.

"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 target," said Bruce Bode, MD, FACE, president of Atlanta Diabetes Associates and associate professor at Emory University School of Medicine, in the Novo 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."