Novo Nordisk’s once-weekly insulin Awiqli® has received FDA approval after phase 3 trials showed effective blood sugar control with a safety profile comparable to daily basal insulin.

Novo Nordisk has announced that the U.S. Food and Drug Administration has approved Awiqli® (insulin icodec-abae) injection 700 units/mL, marking the first and only once-weekly, long-acting basal insulin. The therapy is indicated as an addition to diet and exercise to help improve glycaemic control in adults living with Type 2 Diabetes. This approval introduces a new treatment option designed to align with varying patient routines and preferences by reducing dosing frequency.

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The approval is supported by findings from the ONWARDS phase 3a clinical programme, which included four randomized, active-controlled, treat-to-target trials involving approximately 2,680 adults with uncontrolled type 2 diabetes. In these studies, once-weekly Awiqli® was used alongside mealtime insulin or in combination with commonly prescribed oral anti-diabetic medications and/or GLP-1 receptor agonists. The trials compared the once-weekly insulin with daily basal insulin and demonstrated effectiveness in reducing HbA1c levels, meeting the primary endpoint across the programme. Safety outcomes observed in the ONWARDS trials were generally consistent with those associated with daily basal insulin therapies.

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“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.