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Novo Nordisk announced FDA approval of Awiqli® (insulin icodec-abae), the first and only once-weekly basal insulin for adults with type 2 diabetes, offering an alternative to daily injections. The company expects to launch the product nationwide in the US in the second half of 2026.
Key Takeaways
1FDA approved Awiqli® (insulin icodec-abae) injection 700 units/mL as the first and only once-weekly basal insulin for adults with type 2 diabetes.
2Awiqli® reduces basal insulin injections from seven to one per week for adults with type 2 diabetes.
3Novo Nordisk expects to launch Awiqli® nationwide in the US in the second half of 2026.
4The approval is based on results from the ONWARDS phase 3a programme comprising four trials in approximately 2,680 adults with uncontrolled type 2 diabetes.
5Awiqli® is now approved in the US, EU, and 13 additional countries, with market-specific indications for diabetes.
6Awiqli® will be launched in the FlexTouch® device in the US.