- Awiqli® (insulin icodec) injection, if approved, has the potential to be the first once-weekly basal insulin treatment available in the US for adult type 2 diabetes
- In adults with type 2 diabetes, the ONWARDS clinical trial program evaluated the change in A1C from baseline with Awiqli® compared to daily basal insulin1-5
- Resubmission reflects Novo Nordisk's 100-year legacy of advancing diabetes care
BAGSVÆRD, Denmark and PLAINSBORO, N.J., Sept. 29, 2025 /PRNewswire/ -- Novo Nordisk today announced the resubmission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Awiqli® (insulin icodec) injection, a once-weekly basal insulin treatment for adults living with type 2 diabetes. If approved, Awiqli® would become the first once-weekly basal insulin available in the United States, providing an alternative to daily basal insulin injections for adults living with type 2 diabetes.
"With this resubmission, we're closer to offering a new insulin treatment option for people living with type 2 diabetes that, if approved, could reduce their yearly basal insulin injections from 365 to 52," said Anna Windle, PhD, Senior Vice President, Clinical Development, Medical and Regulatory Affairs at Novo Nordisk. "It is critical that we continue to build upon our 100-year legacy in diabetes and long-standing mission to advance science and the ONWARDS clinical program supports our hope that Awiqli® can help streamline the basal insulin injection regimen for people living with type 2 diabetes."
The resubmission is based on results from the ONWARDS type 2 diabetes phase 3a program for once-weekly Awiqli® which is comprised of five randomized, active-controlled, treat-to-target clinical trials in approximately 4,000 adults with type 2 diabetes. The clinical program evaluated Awiqli® vs. daily basal insulin and the primary endpoint in these trials was change in A1C from baseline.1-5
About Awiqli®
In the US, Awiqli® is an investigational, novel once-weekly basal insulin analog designed to cover the basal insulin requirements for a full week with a single subcutaneous injection. This resubmission is in response to the FDA's action letter received in Q3 2024.
Awiqli® is approved in the EU, along with 12 additional countries. In addition, regulatory filings have been completed in several other countries, with further regulatory decisions expected in 2025.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.
Contacts for further information
References
- Rosenstock J, Bain C. S, Gowda A, et al. Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin. The New England Journal of Medicine. 2023 10.1056/NEJMoa2303208
- 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
- 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
- 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
- Bajaj H, Aberle J, Davies M, et al. Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naïve Type 2 Diabetes (ONWARDS 5). Annals of Internal Medicine. 2023 10.7326/M23-1288
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2025 Novo Nordisk All rights reserved. US25AWQ00001. September 2025
View original content:https://www.prnewswire.co.uk/news-releases/novo-nordisk-resubmits-awiqli-to-the-fda-with-potential-to-be-the-first-once-weekly-basal-insulin-treatment-for-adults-with-type-2-diabetes-302570057.html
