Novo’s Awiqli® receives FDA approval as the first and only once-weekly insulin for children 10 years of age and older with type 2 diabetes

• Awiqli^® offers children 10 years and older a once-weekly basal insulin alternative, reducing basal injection frequency from seven times per week to one¹
• As type 2 diabetes incidence rates among youth continue to rise,² Awiqli^® may help reduce administration barriers associated with daily basal insulin injections and provide families access to more individualized care
• This approval of Awiqli^® reflects Novo’s ongoing efforts to advance healthcare innovation and strengthen support for people living with diabetes and their caregivers

PLAINSBORO, N.J., Oct. 23, 2026 /PRNewswire/ — Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Awiqli^® (insulin icodec-abae) injection 700 units/mL, the first once-weekly, long-acting basal insulin, as an adjunct to diet and exercise to improve glycemic control (blood sugar) in children 10 years of age and older with type 2 diabetes.¹ This approval offers a once-weekly basal insulin treatment option, which reduces the frequency of weekly basal injections from seven to one per week.¹

“Individuals with type 2 diabetes and their families seek treatment options that may allow for more individualized care. Awiqli^® reduces basal insulin injections from seven to one per week, which may help patients find a basal insulin routine that feels more manageable,” said Michael Radin, MD, executive medical director at Novo. “It is important to continue to discover advanced treatments for the populations that need them today.”

Type 2 diabetes in children and adolescents is a growing public health challenge, as more young people are being diagnosed each year with this chronic disease that requires ongoing care and caregiver support.³ According to a modeling study, it’s anticipated that the number of people ≤19 years old with type 2 diabetes is estimated to reach nearly 84,000 by 2050.⁴ Healthy nutrition, physical activity, and family support are important aspects of care for type 2 diabetes.² However, for some young people, these measures may not be enough, potentially leading to complications related to this disease.⁵ Novo’s approach to pediatric care emphasizes a comprehensive model of support – promoting healthy nutrition, regular physical activity, and diabetes education, alongside proven, age-appropriate treatment options for children and adolescents living with type 2 diabetes.² 

This approval is supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes mellitus and a single-dose pharmacokinetic study completed in pediatric patients that evaluated the pharmacokinetic properties of once-weekly Awiqli^® injection in pediatric patients (10 to <18 years of age) with type 2 diabetes.⁶ These results support the use of Awiqli^® in pediatric patients (at least 10 years of age and older), along with the efficacy and safety demonstrated in the pivotal ONWARDS clinical trial program.^6,9 Common side effects of Awiqli^® may include: hypoglycemia (low blood sugar), serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain.¹

“Children with type 2 diabetes face an aggressive disease trajectory and achieving sustained glycemic control in children with type 2 diabetes remains a major challenge. We need treatments that are not only effective but options that work for different patient routines. Having alternative options available for basal insulin therapy allows patients to find a treatment that works best for them and their lifestyle and helps them manage their type 2 diabetes. For more than 20 years daily basal insulin injections have been a main form of treatment in pediatric diabetes care, but children living with type 2 diabetes may face challenges staying on a daily treatment routine,” said Eda Cengiz, MD, MHS Professor of Pediatrics at the University of California, San Francisco. “Having an FDA-approved, once-weekly basal insulin injection available could provide new alternatives for pediatric clinical care. Offering a once-weekly basal insulin may help reduce administration barriers associated with daily insulin injections and provide clinicians and families access to more individualized care.”

Awiqli^® is available at more than 70,000 pharmacies nationwide. More information can be found at www.awiqli.com.

Please see below for Important Safety Information and please click here for the full Prescribing Information.

About Awiqli^®

Awiqli^® (insulin icodec-abae) injection 700 units/mL is a prescription medicine and is the first and only FDA-approved once-weekly basal insulin indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes.¹ Awiqli^® is designed as an alternative to daily basal insulin and its FDA approval is supported by the ONWARDS clinical program, which evaluated its efficacy and safety across insulin-naive patients and previously treated with insulin patient populations living with type 2 diabetes. This approval is supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes mellitus and a single-dose pharmacokinetic study completed in pediatric patients that evaluated the pharmacokinetic properties of once-weekly Awiqli^® injection in pediatric patients (10 to <18 years of age) with type 2 diabetes.⁶ These results support the use of Awiqli^® in pediatric patients (at least 10 years and older), along with the efficacy and safety demonstrated in the pivotal ONWARDS clinical trial program.^6-10 Awiqli^® is administered once-weekly on the same day each week using the Awiqli^® FlexTouch^® pen.¹ Awiqli^® is approved in the US, EU, and 18 additional countries, with market-specific indications for diabetes.

What is Awiqli?

• Prescription Awiqli^® (insulin icodec-abae) injection 700 units/mL is a long-acting insulin (U-700) that is used to control high blood sugar in adults and children who are 10 years of age and older with type 2 diabetes mellitus
• It is not known if Awiqli^® is safe and effective in children less than 10 years of age
• Awiqli^® is available in 1 concentration: U-700

Important Safety Information

Do not share your Awiqli^® FlexTouch^® pen or needles 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.

Make sure you use the right type and dose of insulin. Always check the label on your insulin pen before each injection to avoid mix-ups with Awiqli^® and other insulin products or injectable medicines used to treat diabetes. If you use another injectable medicine to treat your diabetes, pay close attention to how you select your Awiqli^® dosage. The dosage of Awiqli^® is different from other injectable medicines used to treat diabetes.

Always make sure that you select the correct dosage of your Awiqli^® FlexTouch^® pen as prescribed by your healthcare provider, to avoid dosing errors and accidental overdose. People who are blind or have vision problems should not use this pen without help from a person trained to use the pen.

Do not dial the maximum single dosage (700 units) of your Awiqli^® FlexTouch^® pen, unless prescribed by your healthcare provider.

Do not use a syringe to withdraw Awiqli^® from your pen.

Talk to your healthcare provider if you have any questions about how to correctly dose Awiqli^® FlexTouch^®.

Who should not take Awiqli^®?

Do not take Awiqli^® if you:

• are having an episode of low blood sugar (hypoglycemia)
• have an allergy to Awiqli^® or any of the ingredients in Awiqli^®. See the full Patient Information for a complete listing of ingredients in Awiqli^® 

Before taking Awiqli^®, tell your healthcare provider about all your medical conditions, including if you:

• have liver or kidney problems
• take other medicines, especially ones called TZDs (thiazolidinediones)
• have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Awiqli^®
• are pregnant, planning to become pregnant, or are breastfeeding
• are taking new prescription or over-the-counter medicines, vitamins, or herbal supplements

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

How should I take Awiqli^® FlexTouch^®?

• Read the Instructions for Use that come with your Awiqli^® FlexTouch^® pen
• Your healthcare provider should show you how to use Awiqli^® FlexTouch^® pen before you use it for the first time
• Take Awiqli^® exactly as your healthcare provider tells you to. Do not do any conversion of your dose. The dose counter always shows the selected dose in units. Awiqli^® FlexTouch^® pens are made to deliver your insulin dose in units
• Know the type and strength of insulin you take. Do not change the type of insulin you take unless your health care provider tells you to. The amount of insulin and best time for you to take your insulin may need to change if you take different types of insulin
• Inject Awiqli^® FlexTouch^® 1 time each week on any day of the week on the same day each week
• If you need to change the day of the week, you may do so if your last dose has been at least 4 days
• If you have missed your dose, take your missed dose as soon as possible as long as it has been 4 days or less. Then continue the 1 time each week schedule 1 week from the day your missed dose was taken
• If more than 4 days have passed, skip the missed dose and take your next Awiqli^® dose on your regularly scheduled day.
• Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them
• Never inject Awiqli^® FlexTouch^® into a vein or muscle or use Awiqli^® in an infusion pump
• Never use a syringe to remove Awiqli^® from the FlexTouch^® pen
• Do not dilute or mix Awiqli^® with any other insulin or solution
• Awiqli^® FlexTouch^® can be injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen)
• Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) 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
• Keep Awiqli and all medicines out of the reach of children.

What should I avoid while taking Awiqli^®?

• Do not drive or operate heavy machinery, until you know how Awiqli^® affects you
• Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol

What are the possible side effects of Awiqli^®?

Awiqli^® may cause serious side effects that can be life-threatening, including:

• Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include: dizziness or light-headedness, sweating, confusion, fast heartbeat, blurred vision, slurred speech, shakiness, anxiety, irritability, mood changes, hunger and headache
• Severe allergic reactions (whole body reaction). Stop using Awiqli and get medical help right away, if you have any of these signs or symptoms of a severe allergic reaction: a rash over your whole body, trouble breathing, a fast heartbeat or sweating
• Low potassium in your blood (hypokalemia)
• Heart failure in some people if taken with thiazolidinediones (TZDs). This can happen even if you have never had heart failure or heart problems. If you already have heart failure, it may get worse while you take TZDs with Awiqli^®. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet, and sudden weight gain

Your insulin dose may need to change because of change in level of physical activity or exercise, increased stress, change in diet, weight gain or loss, or illness

Common side effects may include: hypoglycemia, serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain

Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion

These are not all the possible side effects of Awiqli^®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please click here for the full Prescribing Information.

Novo is the global healthcare company that believes lasting health starts now. For over a century, we’ve combined leading scientific expertise with a deep understanding of people’s lives. We develop treatments and support that help millions of people make progress they can see, feel and sustain now and in the future. Through our partnerships, programs and investments, we’re working to prevent disease, expand access to treatments and reduce our environmental impact to help even more people live healthier lives. In the United States, Novo has a 40-year presence, is headquartered in New Jersey and employs approximately 10,000 people. For more information, visit novonordisk-us.com and follow us on Instagram, LinkedIn, TikTok, Facebook, X and YouTube.

AWIQLI, NOVO NORDISK, NOVO, and the Apis Bull Logo are trademarks owned by Novo Nordisk A/S.

© 2026 Novo Nordisk All rights reserved. US26AWQ00090 October 2026

_______________________

References:

1. Awiqli^® (insulin icodec-abae) [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
2. American Diabetes Association Professional Practice Committee for Diabetes. (2026). 14. Children and adolescents: Standards of Care in Diabetes—2026. Diabetes Care, 49(Supplement 1), S297–S320. https://doi.org/10.2337/dc26-S014
3. Reinehr T. Type 2 diabetes mellitus in children and adolescents. World J Diabetes. 2013;4(6):270-281. doi:10.4239/wjd.v4.i6.270
4. Imperatore G, Boyle JP, Thompson TJ, et al. Projections of type 1 and type 2 diabetes burden in the U.S. population aged <20 years through 2050: dynamic modeling of incidence, mortality, and population growth. Diabetes Care. 2012 Dec;35(12):2515-20. doi: 10.2337/dc12-0669. PMID: 23173134; PMCID: PMC3507562
5. Bjornstad P, Drews KL, Caprio S, et al; TODAY Study Group. Long-term complications in youth-onset type 2 diabetes. N Engl J Med. 2021;385(5):416-426. doi:10.1056/NEJMoa2100165
6. Van Name M, Ásbjörnsdóttir B, Gomes MM, et al. Pharmacokinetic properties of once-weekly insulin icodec in children and adolescents with type 2 diabetes. Pediatr Diabetes. 2025;2025:5514927. doi:10.1155/pedi/5514927
7. Lingvay I, Asong M, Desouza C, et al. Once-weekly insulin icodec vs once-daily insulin degludec in adults with insulin-naive type 2 diabetes: the ONWARDS 3 randomized clinical trial. JAMA. 2023;330(3):228–237. doi:10.1001/jama.2023.11313
8. Rosenstock J, Gowda A, Liang B. Weekly icodec versus daily glargine U100 in type 2 diabetes without previous insulin. N Engl J Med. 2023;389(16):1533. doi:10.1056/NEJMc2310221
9. Philis-Tsimikas A, Asong M, Franek E, et al. Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol. 2023 https://doi.org/10.1016/S2213-8587(23)00093-1
10. Mathieu C, Ásbjörnsdóttir B, Bajaj H, et al. Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial. 2023 https://doi.org/10.1016/S0140-6736(23)00520-2

View original content to download multimedia:https://www.prnewswire.com/news-releases/novos-awiqli-receives-fda-approval-as-the-first-and-only-once-weekly-insulin-for-children-10-years-of-age-and-older-with-type-2-diabetes-302918384.html

SOURCE Novo Nordisk