FDA approves rapid-acting insulin for pump use
The FDA expanded the indication for insulin aspart injection 100 U/mL to include use in insulin infusion pumps for the improvement of glycemic response in adults with type 1 and type 2 diabetes, according to a press release from Novo Nordisk.
The FDA approved insulin aspart (Fiasp), a rapid-acting injection, in 2017 for use by IV infusion under supervision by a health care professional or by subcutaneous multiple daily injection (MDI) in adults with diabetes. The insulin aspart injection was a new formulation of NovoLog that includes niacinamide, which helps increase the speed of insulin absorption. The therapy was designed to mimic the natural physiologic insulin response that occurs after meals.
“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, MD, vice president and U.S. chief medical officer of Novo Nordisk, said in the release. “Since the launch of Fiasp, we’ve heard time and again from the diabetes community about the need to make it available for adult insulin pump users. 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.”
Insulin aspart is available in 10 mL vials for use in insulin pumps or MDI, 3 mL FlexTouch pens for MDI, and 3 mL PenFill cartridges for the NovoPen Echo for MDI. Insulin aspart should be used in accordance with the insulin pump’s instructions for use.
The label change is based on the FDA’s review of data from the ONSET-5 clinical trial, which confirmed the efficacy and safety of insulin aspart when used in insulin infusion pumps in adults with diabetes. In ONSET-5, the rapid-acting insulin was well tolerated and effective in pumps releasing steady doses throughout the day and during mealtime doses, according to the release. The pump should be programmed based on guidance from health care providers and the pump maker’s instructions.
Disclosure: Hobbs is vice president and U.S. chief medical officer of Novo Nordisk.