FDA Clears Fiasp for Use in Insulin Infusion Pumps

Fiasp Insulin Aspart Injection Product Photo, Courtesy of Norvo Nordisk

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Back in 2017, the FDA approved Fiasp, a rapid-acting insulin, for use by IV infusion under supervision by a healthcare professional or by subcutaneous multiple daily injection (MDI) in adults with diabetes. It is currently the only insulin injection that does not have a pre-meal dosing recommendation. Novo Nordisk, a global healthcare company and the creator of Fiasp, announced the FDA’s clearance to expand the label use for its 100 u/mL insulin aspart injection. This expansion allows it to be used in insulin infusion pumps, which will improve glycemic control in adults who have type 1 or type 2 diabetes. The expansion of Fiasp’s label use is based on the onset 5 clinical trial, where the FDA reviewed and was able to validate its efficacy and safety.

When looking into the insulin segment of the diabetes market, iData found that, although the number of insulin-dependent diabetics is rising in the United States, insulin manufacturers have experienced tremendous backlash from consumers and diabetes associations. Patients are frustrated in regards to the unreasonable rise in insulin prices over the last several decades. Insulin prices in the United States are among the highest in the world, which has forced patients to extend the usage life of their insulin and choose cost-sensitive therapy options, such as human insulin. While Novo Nordisks’ Fiasp improves patient care for both type 1 and type 2 diabetic patients, pricing barriers, such as a high ASP, will limit positive market growth.

“People living with diabetes are looking for treatment options that fit into their lifestyles and shifting schedules, and for many, an insulin pump is an important part of their regimen,” said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk.

Todd added that the “label update will now enable adult patients to use Fiasp® in their pumps, which is an important part of our ongoing commitment to patient choice and meeting the needs of people living with type 1 and type 2 diabetes.”


For Further Information

To get in an in-depth market overview, as well as insight through primary research and procedural volumes from 16 countries, please read iData Research’s’ 754 page Diabetes Market Analysis, Size, and Trends Report.

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