Novo Nordisk’s Awiqli receives FDA approval for type 2 diabetes patients

UAE—Novo Nordisk has secured FDA approval for Awiqli® (insulin icodec-abae) injection 700 units/mL, making it the first and only once-weekly, long-acting basal insulin available in the United States.

The drug is indicated as an adjunct to diet and exercise to improve blood sugar control in adults living with type 2 diabetes, and its approval signals a meaningful shift in how patients can manage their condition.

Until now, basal insulin required daily injections—a routine that many patients find burdensome.

Awiqli® changes that by offering a single weekly dose, giving patients greater flexibility to fit treatment into their individual lifestyles and preferences.

What the clinical evidence shows

The FDA’s decision rests on results from the ONWARDS phase 3a programme, a series of four randomised, active-controlled, treat-to-target trials involving approximately 2,680 adults with uncontrolled type 2 diabetes.

Researchers tested Awiqli® both alongside mealtime insulin and in combination with common oral anti-diabetic agents and GLP-1 receptor agonists.

Across all four trials, once-weekly Awiqli® demonstrated efficacy against daily basal insulin in the primary endpoint of HbA1c reduction — a key measure of long-term blood sugar control.

Notably, its overall safety profile remained consistent with that of the existing daily basal insulin class, giving clinicians a familiar risk framework when considering it for their patients.

Mike Doustdar, President and CEO of Novo Nordisk, described the approval as a reflection of the company’s broader commitment to advancing healthcare innovation for people living with diabetes.

He highlighted that Awiqli® introduces an important new treatment pathway at a time when some industry players are pulling back from insulin development.

Rather than retreating, Novo Nordisk is doubling down — continuing to invest in innovation, access, and supply for the millions of patients who depend on insulin daily.

Availability and global reach

Novo Nordisk plans to launch Awiqli® in the US in the second half of 2026, delivered via the FlexTouch® device.

The insulin is already approved in the European Union and 13 additional countries, with indications varying by market.

The US approval adds to a growing global footprint for the drug, positioning Novo Nordisk to reach a wider patient population with what it considers a more convenient and patient-centred approach to basal insulin therapy.