FDA Expands Approval for Fiasp to Include Insulin Infusion Pumps


The rapid-acting insulin will now be used in infusion pumps to treat adults with Type 1 or Type 2 diabetes.

The US Food and Drug Administration (FDA) is expanding the label for Fiasp, a 100 u/ml insulin aspart injection to include use in insulin infusion pumps for the improvement of glycemic control in adults with Type 1 and Type 2 diabetes.

Fiasp, developed by Novo Nordisk, is a rapid-acting insulin used by intravenous infusion under the supervision of a healthcare professional or by subcutaneous multiple daily injection (MDI) in adults with diabetes.

The treatment was first approved by the FDA in 2017.

The label change is based on the FDA’s data review from the onset 5 clinical trial, which confirmed the efficacy and safety of the treatment when used in insulin infusion pumps in adults with diabetes.

Fiasp has shown to be well-tolerated and effective in pumps that release steady doses of insulin throughout the day and during meals.

The medication is currently available in multiple dosing options for multiple daily injections and continuous subcutaneous insulin infusion, including a 10 mL vial for insulin pumps or MDI, a 3 mL FlexTouch for MDI, and a 3 mL PenFill Cartridge for NovoPen Echo for MDI.

"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," Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk, said in a statement. "This 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."

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