FDA approves Fiasp® for 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

Indications and Usage

What is Fiasp^® (insulin aspart injection) 100 U/mL?

• Fiasp^® is a man-made insulin used to control high blood sugar in adults and children with diabetes mellitus.

Important Safety Information
Do not share your Fiasp^® with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

Who should not take Fiasp^®?
Do not take Fiasp^® if:

• your blood sugar is too low (hypoglycemia) or you are allergic to any of its ingredients.

Before taking Fiasp^® tell your health care provider about all your medical conditions including, if you:

• have kidney or liver problems
• are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Fiasp^® passes into your breast milk.
• are taking new prescription or over-the-counter medicines, including supplements.

Talk to your health care provider about low blood sugar and how to manage it.

How should I take Fiasp^®?

• Read the Instructions for Use and take Fiasp^® exactly as your health care provider tells you to.
• Fiasp^® starts acting fast. You should take your dose of Fiasp^® at the beginning of the meal or within 20 minutes after starting a meal.
• Know the type and strength of your insulin. Do not change your insulin type unless your health care provider tells you to.
• Change (rotate) your injection sites within the area you choose with each injection to reduce your risk of getting pits in skin or thickened skin (lipodystrophy) and skin with lumps (localized cutaneous amyloidosis) at the injection sites.
• Do not use the exact same spot for each injection.
• Do not inject where the skin has pits, is thickened, or has lumps.
• Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
• If you miss a dose of Fiasp^® monitor your blood sugar levels to decide if an insulin dose is needed. Continue with your regular dosing schedule at the next meal.
• Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them.
• Do not reuse or share your needles with other people. You may give other people a serious infection or get a serious infection from them.

What should I avoid while taking Fiasp^®?

• Do not drive or operate heavy machinery, until you know how Fiasp^® affects you.
• Do not drink alcohol or use medicines that contain alcohol.

What are the possible side effects of Fiasp^®?
Serious side effects can lead to death, including:

• Low blood sugar (hypoglycemia). Some signs and symptoms include: anxiety, irritability, mood changes, dizziness or light-headedness, sweating, confusion, and headache.
• low potassium in your blood (hypokalemia).
• serious allergic reactions (whole body reactions). Get emergency medical help right away if you have a rash over your whole body; trouble breathing; a fast heartbeat; swelling of your face, tongue or throat; sweating; extreme drowsiness; dizziness, or confusion.
• heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with Fiasp^® may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Fiasp^®. Your health care provider should monitor you closely while you are taking TZDs with Fiasp^®. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, swelling of your ankles or feet, or sudden weight gain.

Your insulin dose may need to change because of:

• weight gain or loss, increased stress, illness, or change in diet or level of physical activity

Common side effects of Fiasp^® may include:

• skin problems such as eczema, rash, itching, redness and swelling of your skin (dermatitis), reactions at the injection site such as itching, rash, skin thickening or pits at the injection site (lipodystrophy), or weight gain.

Please see Prescribing Information for Fiasp at http://www.novo-pi.com/fiasp.pdf

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.

Fiasp^® is a registered trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2019 Novo Nordisk    All rights reserved.     US19FSP00240    December 2019

SOURCE Novo Nordisk