The type 2 diabetes injection reduces administration frequency from daily to once per week, enhancing convenience for patients.
The US Food and Drug Administration (FDA) has approved a once-weekly, long-acting basal insulin treatment for type 2 diabetes for the first time.
Novo Nordisk’s Awiqli (insulin icodec-abae) injection 700 units/mL provides a more convenient alternative to daily insulin as it is delivered via a prefilled pen.
The subcutaneous treatment is authorised as an adjunct therapy to diet and exercise to improve glycaemic control in adults.
The FDA’s decision was based on clinical data from the ONWARDS phase IIIa programme that evaluated the once-weekly injection alongside a mealtime insulin or in combination with common oral anti-diabetic agents and/or GLP-1 receptor agonists. Awiqli showed efficacy in the primary endpoint of HbA1c reduction, which could improve glycaemic control, especially in individuals prone to glycaemic excursions.
Named as a ‘drug to watch’ in a report by analytics firm Clarivate in 2025, Awiqli’s potential blockbuster status is reinforced with this latest approval by the US medicine agency.
As the first FDA-approved, once-weekly basal insulin for adults with type 2 diabetes, it offers an important new treatment option”
Mike Doustdar, President and CEO of Novo Nordisk, said: “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.”
Europe has received two nods in diabetes over the past several months. Novo Nordisk last year gained recommendation from the CHMP for its insulin-semaglutide injection Kyinsu in type 2 diabetes. Then in January, Sanofi won approval in Europe for its type 1 diabetes biologic Teizeild (teplizumab), making it the first disease-modifying treatment for the condition in the region. The immunotherapy obtained MHRA approval last August prior to the European Commission’s decision.
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