FDA OKs Faster-Acting Insulin Aspart for
Pump Use

Miriam E. Tucker

October 22, 2019

The US Food and Drug Administration (FDA) has expanded the indication for the more rapid-acting version of insulin aspart (Fiasp, Novo Nordisk) for use in insulin pumps.

Injectable and intravenous forms of Fiasp (insulin aspart injection 100 units/mL) were first approved in the United States in 2017 after an initial launch in Canada and Europe earlier that year.

The original approval in Europe covered the use of Fiasp in insulin pumps but the Canadian and US approvals did not.

The new US indication is for use in insulin pumps in adults with type 1 or type 2 diabetes

In Fiasp, niacinamide (vitamin B3) has been added to aspart to help increase the speed of the initial insulin absorption. For mealtime use, it is indicated to be dosed at the beginning of a meal or within 20 minutes after starting a meal, and appears in the blood approximately 2.5 minutes after dosing.

There are approximately 350,000 insulin pump users in the US, according to Novo Nordisk. According to the device's instructions, Fiasp should be used in pumps, as with other short-acting insulins.

The label expansion to include use in insulin pumps was based on data from ONSET 5 a randomized, multicenter, multinational trial that compared efficacy and safety of continuous subcutaneous insulin infusion of Fiasp to that of regular insulin aspart (NovoLog/NovoRapid) in adults with type 1 diabetes.

Fiasp continues to be available in three dosing options: a 10 mL vial, 3 mL FlexTouch pen, and a 3 mL Penfill Cartridge for NovoPen Echo.

The vial is now approved for pump as well as multiple daily injection use.

"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," said Todd Hobbs, vice president and US chief medical officer of Novo Nordisk, in a press release.  

For information on cost and savings offers, including copay and patient assistance programs, visit novocare.com.

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