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FDA Approves Fiasp (insulin aspart injection) for the Treatment of Children with Diabetes

PLAINSBORO, N.J., Jan. 6, 2020 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Fiasp (insulin aspart injection) 100 u/mL for use as a new mealtime insulin option for children with diabetes.1 Fiasp is the first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation. Fiasp is now available for use in children and adults in three different dosing options: multiple daily injections (MDI), continuous subcutaneous insulin infusion pumps and intravenous infusion under supervision by a healthcare professional.

Diabetes is one of the most common chronic conditions diagnosed in childhood, with nearly 18,000 new cases of type 1 diabetes each year.2,3 Managing diabetes can be challenging for parents and caregivers given it is hard to know exactly how much or how quickly their children will eat, making mealtime insulin dosing difficult.3,4,5 Conventional rapid-acting insulins must be administered ahead of meals, which requires some guesswork to dose properly, and children living with diabetes may not achieve adequate blood sugar control.3,4,5,6

"As a parent of a son living with type 1 diabetes, I know first-hand how tough it can be to address the inevitable blood sugar spikes around mealtimes," said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. "Children can be unpredictable and having the option of a fast-acting insulin that doesn't require pre-meal dosing like Fiasp is a welcome development for the diabetes community."

The approval is based on the FDA's review of data from the onset 7 clinical trial, which confirmed the efficacy and safety of Fiasp in children. 7

For information on cost and savings offers, including co-pay and patient assistance programs, visit myfiaspcost.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 7

The approval of Fiasp for pediatric use was based on data from onset 7, a 26-week, phase 3b, partially double-blind, basal-bolus, treat-to-target trial, which investigated the efficacy and safety of Fiasp® compared with conventional insulin aspart in 777 children with type 1 diabetes.7

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

  1. Fiasp [package insert]. Plainsboro, NJ: Novo Nordisk Inc; December 2019.
  2. Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf Accessed November 2019.
  3. Streisand R and Monaghan M. Young children with type 1 diabetes: Challenges, research, and future directions. Current Diabetes Reports 2014; 14(9): 520: 
  4. Wysocki T, et al. Adjustment to diabetes mellitus in preschoolers and their mothers. Diabetes Care 1989; 12(8):524-29.
  5. Øverby NC, et al. Sweets, snacking habits, and skipping meals in children and adolescents on intensive insulin treatment. Pediatric diabetes 2008; 9:393-400.
  6. Wood MD, et al. Most Youth With Type 1 Diabetes in the T1D Exchange Clinic Registry Do Not Meet American Diabetes Association or International Society for Pediatric and Adolescent Diabetes Clinical Guidelines. Diabetes Care 2013;36(7):2035-7. doi: 10.2337/dc12-1959.
  7. Bode BW, et al. Efficacy and Safety of Fast-Acting Insulin Aspart Compared with Insulin Aspart, Both in Combination with Insulin Degludec, in Children and Adolescents with Type 1 Diabetes: The onset 7 Trial. Diabetes Care 2019; 42(7):1255-1262.

SOURCE Novo Nordisk

Posted: January 2020

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Fiasp (insulin aspart) FDA Approval History

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