FDA approves Fiasp? for use in insulin infusion pumps for adults with type 1 or type 2 diabetes

發(fā)布時間： 2019-10-30 閱讀：979次

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Oct. 22, 2019 -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has expanded the label for Fiasp? (insulin aspart injection) 100 u/mL to include use in insulin infusion pumps for the improvement of glycemic control in adults with type 1 or type 2 diabetes.1 Fiasp?, a rapid-acting insulin, was approved by the FDA in 2017 for use by intravenous infusion under supervision by a healthcare professional or by subcutaneous multiple daily injection (MDI) in adults with diabetes.

There are estimated to be more than 350,000 insulin infusion pump users in the U.S.2,3,4 An insulin pump is a small, programmable, battery-operated device that delivers insulin under the skin. Fiasp? should be used in accordance with the insulin pump's instructions for use. Fiasp? is available in multiple dosing options for multiple daily injections (MDI) as well as continuous subcutaneous insulin infusion1:

（1）10 mL vial for use in insulin pumps or MDI

（2）3 mL FlexTouch? for MDI

（3）3 mL PenFill? Cartridge for NovoPen Echo for MDI

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 Fiasp? when used in insulin infusion pumps in adults with diabetes. 5 Fiasp? has been shown to be well-tolerated and effective in pumps releasing steady doses throughout the day and mealtime doses during meals. The pump should be programmed based on guidance from healthcare providers and the pump maker's instructions.

"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. "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."