Novo Nordisk has resubmitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its 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,” she added.
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.
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 the third quarter of 2024.
Awiqli is approved in the European Union, along with 12 additional countries. In addition, regulatory filings have been completed in several other countries, with further regulatory decisions expected in 2025.
AWIQLI CA WEBSITE PHOTO