A
A
A

诺和诺德宣布用于治疗成人2型糖尿病的Awiqli®已在美国上市

·in 7 hours发布

  • Awiqli® offers adults with type 2 diabetes an alternative to daily basal insulin injections, reducing frequency of these weekly basal injections from seven to one per week1

  • Awiqli® will be available at over 70,000 pharmacies nationwide

  • Affordability programs can be found through NovoCare.com, where eligible patients can pay as little as $35 per month

 

PLAINSBORO, N.J., Aug. 11, 2026 /PRNewswire/ -- Novo Nordisk today announced the nationwide launch of Awiqli® (insulin icodec-abae) injection 700 units/mL, the first once-weekly basal insulin approved as an adjunct to diet and exercise to improve glycemic control (blood sugar) in adults living with type 2 diabetes,1 following the U.S. Food and Drug Administration (FDA) approval earlier this year.

 

"Awiqli® represents meaningful progress in the options available for basal insulin therapy for the millions of adults with type 2 diabetes" said Tom Scales, Senior Vice President of Market Access & Public Affairs and Patient Support Solutions at Novo Nordisk. "As the only once-weekly basal insulin available in the US, Awiqli® reduces the frequency of daily basal injections from seven to one per week. Our focus is ensuring broad access so interested, eligible adults with type 2 diabetes have the support they need to talk to their doctor about starting Awiqli®."

 

Clinical studies support simplifying treatment regimens for adults with type 2 diabetes.2 Daily basal insulin routines can be challenging for some patients, and less frequent basal dosing support may help reduce this common barrier to basal insulin therapy.2 By offering a once-weekly dosing profile delivered via the prefilled FlexTouch® pen, Awiqli® may help patients with a basal insulin routine that feels more manageable.

 

The FDA approval was based on results from the ONWARDS type 2 diabetes phase 3a program for once-weekly Awiqli® injection which evaluated Awiqli® administered once-weekly in adult patients with type 2 diabetes, used in combination with a mealtime insulin or in combination with common oral anti-diabetic agents and/or GLP-1 receptor agonist, in three randomized, open-label, treat-to-target, active-controlled trials and one randomized, double-blind, treat-to-target, active-controlled trial. The clinical program evaluated once-weekly Awiqli® vs daily basal insulin and demonstrated efficacy in the primary endpoint of non-inferiority in mean change in HbA1c from baseline to trial end across the ONWARDS pivotal clinical trial program for adults with type 2 diabetes.

 

Across five ONWARDS trials, the safety profile of Awiqli® was overall consistent with the daily basal insulin class used in each trial.3-6 Common adverse events 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

 

Awiqli® is now accessible to the millions of adults with type 2 diabetes who may benefit from it, and appropriate patients can access it at retail pharmacies nationwide. In addition, to support adults with type 2 diabetes, Novo Nordisk offers a Patient Education Center through NovoCare.com which includes patient educational resources and tools, healthy recipes, and affordability offerings for eligible patients to help lower out-of-pocket costs to as little as $35 per month for those who qualify.

 

For more information on Awiqli®, clinical trial data, and prescribing information, please visit Awiqli.com.

 

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 with type 2 diabetes.1 Awiqli® is designed as an alternative to daily basal insulin and its approval is supported by the ONWARDS clinical program, which evaluated its efficacy and safety across diverse adult populations living with type 2 diabetes.3-6 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 13 additional countries, with market-specific indications for diabetes.

 

About Novo Nordisk  


Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine 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 a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs approximately 10,000 people throughout the country across more than 10 manufacturing, R&D and corporate locations in seven states plus Washington DC.

 

References

  1. Awiqli® (insulin icodec-abae) [package insert]. Plainsboro, NJ: Novo Nordisk Inc.

  2. Jude E, Malecki M, Huelgas R, et al. Expert panel guidance and narrative review of treatment simplification of complex insulin regimens to improve outcomes in type 2 diabetes. Diabetes Ther. 13, 619–634 (2022). https://doi.org/10.1007/s13300-022-01222-2

  3. 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

  4. 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

  5. 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

  6. 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

 

文章关键词： 诺和诺德成人2型糖尿病Awiqli®
下载PDF
0
发布文章
0
关注人数