PLAINSBORO, N.J., Oct. 22, 2019 /PRNewswire/ — 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 diabetes 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:
- 10 mL vial for use in insulin pumps or MDI
- 3 mL FlexTouch® for MDI
- 3 mL 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,” 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.”
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.1
For information on cost and savings offers, including co-pay and patient assistance programs, visit Novocare.com.
About Fiasp
Fiasp is the first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation. Fiasp is administered at the beginning of a meal or within 20 minutes after starting a meal.
About onset 5
The Fiasp label expansion to include use in insulin infusion pumps for the improvement of glycemic control in adults with type 1 or type 2 diabetes was based on data from onset 5, a randomised, multicenter, multinational trial, which investigated the efficacy and safety of continuous subcutaneous insulin infusion of Fiasp compared to NovoLog in adults with type 1 diabetes.5
About Novo Nordisk
Novo Nordisk is a global healthcare company that’s been making innovative medicines to help people with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in six states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit novonordisk.us, Facebook, Instagram and Twitter.
References
- Fiasp [package insert]. Plainsboro, NJ: Novo Nordisk Inc; October 2019.
- Diabetes Care. 2015 Apr;38(4):716-22. doi: 10.2337/dc15-0168.
- J Clin Med. 2016 Jan; 5(1): 5. Published online 2016 Jan 4. doi: 10.3390/jcm5010005
- Diabetes Care. 2018 Aug;41(8):1579-1589. doi: 10.2337/dci18-0002. Epub 2018 Jun 23.
- Klonoff D, et al. Diabetes Obes Metab. 2019;21:961–967. doi: 10.1111/dom.13610
SOURCE Novo Nordisk
Posted: October 2019
