Novo Nordisk announced that the U.S. Food and Drug Administration approved its once‑weekly basal insulin, Awiqli, on March 26 2026. The approval marks the first FDA‑approved once‑weekly insulin, offering patients with type 2 diabetes a single injection per week instead of daily injections and potentially improving adherence and quality of life.
The approval was based on the ONWARDS phase 3a program, which enrolled approximately 2,680 adults with uncontrolled type 2 diabetes. The four randomized, active‑controlled trials demonstrated that Awiqli lowered HbA1c levels comparably to daily basal insulin while maintaining a safety profile consistent with the class. The program also identified a higher rate of level 2 or 3 hypoglycemia in the Acodec group, underscoring the need for patient education on hypoglycemia risk.
Novo Nordisk’s diabetes and obesity care segment generated DKK 289.46 billion of its 2025 sales of DKK 309.06 billion, underscoring the segment’s importance to the company’s top line. Gross margin fell to 81 % in 2025 from 84.7 % in 2024, largely due to amortization and restructuring costs. Management has indicated that the launch of Awiqli could help offset this margin pressure, and the company’s 2026 guidance reflects pricing headwinds and an expected sales decline in U.S. operations.
"The Awiqli® approval reflects Novo Nordisk's ongoing efforts to advance healthcare innovation and strengthen support for people living with diabetes. As the first FDA‑approved, once‑weekly basal insulin for adults with type 2 diabetes, it offers an important new treatment option. At a time when parts of the industry are stepping back from insulin, we are reaffirming our commitment—continuing to invest in innovation, access, and supply for the millions of patients who rely on insulin every day," said Mike Doustdar, president and CEO of Novo Nordisk.
"Awiqli® is an important new option that meets a real need as the first FDA‑approved, once‑weekly basal insulin for adult patients with type 2 diabetes. It's helping to reframe what basal insulin care can look like," added Anna Windle, PhD, Group Vice President, Clinical Development, Medical & Regulatory Affairs.
The company plans to launch Awiqli in the U.S. using its FlexTouch device in the second half of 2026, expanding its diabetes treatment lineup and positioning Novo to compete more directly with other once‑weekly insulin options entering the market. The approval not only broadens Novo’s portfolio but also signals the company’s continued leadership in insulin innovation amid a broader industry shift away from insulin development.
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