FDA Approves Mealtime Insulin for Use with Infusion Pumps

October 23, 2019

Previously approved for IV infusion.

The FDA has approved Novo Nordisk’s fast-acting insulin aspart injection (Fiasp) for use in insulin infusion pumps for adults with type 1 or type 2 diabetes. 

The rapid-acting human insulin analog was first approved in 2000 and received an expanded indication in 2017 for the use as an intravenous infusion. 

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In a randomized, multicenter, multinational trial (Onset 5), Fiasp was shown to be effective and safe option for CSII treatment in T1D when compared to insulin aspart (IAsp):

  • Fiasp showed non-inferior changes from baseline regarding glycated hemoglobin

  • Fiasp was superior to IAsp regarding change from baseline in 1-hour postprandial glucose increment after a mealo   Statistically significant reductions were recorded at 30 mins and 2 hours 

  •  No statistically significant reductions recorded in overall rate of severe or blood glucose-confirmed hypoglycemia 

"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 in a statement. "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."

 

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