Novo Nordisk A/S (NVO) yesterday announced that the U.S. FDA has approved Awiqli (insulin icodec-abae), the first and only once-weekly basal insulin for adults with type 2 diabetes. The approval comes after a prior FDA rejection in 2024, when regulators issued a Complete Response Letter citing manufacturing concerns and risks in type 1 diabetes. Novo Nordisk resubmitted the application in September 2025, focusing solely on type 2 diabetes, which has now been cleared.
Awiqli offers patients an alternative to daily basal insulin injections, reducing the burden from seven injection per week to just one.
The FDA decision was supported by results from the ONWARDS phase 3a program, which enrolled about 2,680 adults with uncontrolled type 2 diabetes. Across four randomized trials, Awiqli demonstrated significant reductions in HbA1c compared to daily basal insulin, with a safety profile consistent with the class. Novo Nordisk expects to launch Awiqli nationwide in the U.S. in the second half of 2026, using its FlexTouch device.
Awiqli is already approved in the EU and 13 other countries, making this U.S. approval a major milestone in expanding global access. "At a time when parts of the industry are stepping back from insulin, we are reaffirming our commitment," said Mike Doustdar, President and CEO of Novo Nordisk, highlighting the company's continued investment in innovation and supply for millions of patients.
NVO has traded between $35.85 and $81.44 over the past year. The stock is currently trading at $36.19, down 0.52%.
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