Novo Nordisk (NYSE:NVO) said today that it won an expanded label from the FDA for its Fiasp fast-acting insulin aspart injection for use with infusion pumps by adults with Type 1 or Type 2 diabetes.
Fiasp won FDA approval in 2017 for use in intravenous infusion under professional supervision or by subcutaneous multiple daily injection in adults with diabetes.
The FDA granted the label change after reviewing data from the Onset 5 clinical trial, which Novo Nordisk said confirmed the efficacy and safety of Fiasp when used in insulin infusion pumps by adults with diabetes.
Fiasp was well-tolerated and effective in pumps releasing steady doses throughout the day and mealtime doses as well, according to a news release. Fiasp is available in multiple dosing options in a 10mL vial for insulin pumps or MDI, the 3mL FlexTouch for MDI and the 3mL 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,” VP & U.S. chief medical officer Todd Hobbs said in prepared remarks. “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.”
Novo Nordisk’s Fiasp also has clearance in Europe, having won approval in November 2016. In October 2018, Insulet (NSDQ:PODD) announced that its Omnipod insulin management system was available in Europe for use with Fiasp.
Shares of NVO were up 1.5% at $53.40 in mid-afternoon trading today.
