Novo Nordisk Resubmits Insulin Icodec (Awiqli) Injection BLA for Type 2 Diabetes

Novo Nordisk has announced the resubmission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for insulin icodec (Awiqli) injection, a once-weekly basal insulin treatment for adults living with type 2 diabetes.1

According to a September 29, 2025, press release from the Company, the resubmission is based on results from the ONWARDS type 2 diabetes phase 3a program, which comprises 5 randomized, active-controlled, treat-to-target clinical trials in approximately 4000 adults with type 2 diabetes. If approved, insulin icodec 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.1

"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," Anna Windle, PhD, Senior Vice President, Clinical Development, Medical and Regulatory Affairs at Novo Nordisk, said in a statement.1 "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 [insulin icodec] can help streamline the basal insulin injection regimen for people living with type 2 diabetes."

On July 10, 2025, the FDA issued a CRL to Novo Nordisk’s BLA for once-weekly basal insulin icodec, which requests concerning the manufacturing process and the type 1 diabetes indication, which were required to be addressed before the BLA review for insulin icodec could be completed.2

The CRL followed a May 2024 FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting hosted a panel of independent scientific experts to evaluate the benefit-risk profile of once-weekly basal insulin icodec in T1D, which yielded a 7-4 vote determining the available data were insufficient to conclude the benefits of insulin icodec outweigh its risk profile. Of note, the Advisory Committee meeting did not discuss the use of once-weekly insulin icodec in type 2 diabetes.2

As described by Novo Nordisk, the resubmission is based on results from the ONWARDS type 2 diabetes phase 3a program for once-weekly insulin icodec, which includes 5 randomized, active-controlled, treat-to-target clinical trials in approximately 4000 adults with type 2 diabetes. The clinical program evaluated insulin icodec versus daily basal insulin and the primary endpoint in these trials was change in A1C from baseline.1

References

1. Novo Nordisk. Novo Nordisk resubmits Awiqli® to the FDA with potential to be the first once-weekly basal insulin treatment for adults with type 2 diabetes. September 29, 2025. Accessed September 29, 2025. https://www.prnewswire.com/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-302568645.html

2. Iapoce C. FDA Issues Complete Response Letter for Once-Weekly Insulin Icodec. HCPLive. July 11, 2024. Accessed September 29, 2025. https://www.hcplive.com/view/fda-issues-complete-response-letter-for-once-weekly-insulin-icodec