Novo Nordisk has 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 for adults with type 2 diabetes. If approved, Awiqli® would become the first once-weekly basal insulin available in the US, offering an alternative to daily injections and potentially reducing annual basal insulin injections from 365 to just 52.
Anna Windle, PhD, Senior VP, Clinical Development, Medical and Regulatory Affairs, said:
"With this resubmission, we're one step closer to offering adults with type 2 diabetes a new treatment option that could simplify their basal insulin regimen. The ONWARDS clinical program supports our hope that Awiqli® can help streamline insulin therapy."
The ONWARDS phase 3a program included five randomized, active-controlled, treat-to-target trials involving ~4,000 adults with type 2 diabetes. Across these studies, Awiqli® was evaluated against daily basal insulin, with the primary endpoint measuring change in A1C from baseline.
About Awiqli®
Awiqli® is an investigational once-weekly basal insulin analog designed to cover basal insulin requirements for a full week with a single subcutaneous injection. It is already approved in the EU and 12 other countries, with additional regulatory filings underway.
About Novo Nordisk
Founded in 1923 and headquartered in Denmark, Novo Nordisk is a global healthcare leader dedicated to combating serious chronic diseases, with a particular heritage in diabetes. The company employs ~78,400 people across 80 countries and markets products in ~170 countries.
