Salute e Benessere
Novo Nordisk resubmits Awiqli® to the FDA with potential to be the first once-weekly basal insulin treatment for adults 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.
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.
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.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2025 Novo Nordisk All rights reserved. US25AWQ00001. September 2025
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