Fiasp Again Goes Before the FDA for Approval
Novo Nordisk submitted the rapid-acting insulin to the agency in late March.
A new mealtime insulin that has been shown to improve glycemic control for people with Type 1 Diabetes is once again before the FDA for approval. Novo Nordisk announced March 29th that it had resubmitted Fiasp, billed as a faster-acting bolus insulin than what is on the market, for FDA approval. The company expects to receive feedback from the agency in the last quarter of 2017.
Fiasp first became available in Canada, Germany, and the UK, and is scheduled to launch soon throughout Europe. Fiasp is also under regulatory review in Switzerland, Australia, Brazil, South Africa, and Argentina. The resubmission for approval in the United States presumably addresses requests made by the FDA in October 2016 for clarification on data related to safety.
In press materials, Novo Nordisk highlights the flexibility offered by the faster-absorbing insulin, noting that users can safely bolus up to two minutes before a meal and up to 20 minutes after a meal. Fiasp will compete with currently available fast-acting injectable insulins, including Novolog, Humalog, and Apidra, and the inhalable insulin, Afrezza. Each of these insulins begin to work within 30 minutes.
Novo states that Fiasp appears twice as fast in the bloodstream as Novo’s NovoRapid in clinical trials. Novo reports that more 2,100 people with Type 1 Diabetes and Type 2 Diabetes participated in the four-stage trial program in Canada. Trial participants using Fiasp experienced slightly lower A1C levels and lower glucose levels after meals. They did not have an increased risk of severe hyperglycemia overall, but they did have a higher risk of hypoglycemia in the first hour after the start of meals.
Children and adolescents might particularly benefit from increased flexibility around mealtime dosing. However, while children and adolescents did participate in trials in Europe, Fiasp has not yet been approved for children in any market. There also is no indication about what the price for Fiasp will be in the United States, although Novo has said it will be available at “price parity to NovoRapid” in Canada.
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