Awiqli® accepted within the US, the primary and solely once-weekly basal insulin remedy for adults with sort 2 diabetes

Novo Nordisk immediately introduced that the US Meals and Drug Administration (FDA) has accepted Awiqli® (insulin icodec-abae) injection 700 models/mL, the primary and solely once-weekly, long-acting basal insulin, indicated as an adjunct to weight loss program and train to enhance glycaemic management (blood sugar) in adults residing with sort 2 diabetes. The approval presents the one as soon as‑weekly basal insulin choice, offering a brand new remedy answer that matches totally different affected person routines and preferences for adults residing with sort 2 diabetes.

The approval relies on outcomes from the ONWARDS section 3a programme in type-2-diabetes for once-weekly Awiqli® injection, which includes 4 randomised, active-controlled, treat-to- goal trials in roughly 2,680 adults with uncontrolled sort 2 diabetes, utilized in mixture with a mealtime insulin or together with frequent oral anti-diabetic brokers and/or GLP-1 receptor agonists. The scientific programme evaluated once-weekly Awiqli® vs day by day basal insulin and demonstrated efficacy within the main endpoint of HbA1c discount throughout the ONWARDS pivotal scientific trial programme in adults with sort 2 diabetes. Throughout ONWARDS trials, the security profile of Awiqli® was general per the day by day basal insulin class.

“The Awiqli® approval displays Novo Nordisk’s ongoing efforts to advance healthcare innovation and strengthen assist for individuals residing with diabetes. As the primary FDA-approved, once-weekly basal insulin for adults with sort 2 diabetes, it presents an necessary new remedy choice. At a time when components of the trade are stepping again from insulin, we’re reaffirming our dedication – persevering with to put money into innovation, entry, and provide for the thousands and thousands of sufferers who depend on insulin daily,” mentioned Mike Doustdar, president and CEO of Novo Nordisk.

Novo Nordisk expects to launch Awiqli® within the FlexTouch® machine within the US within the second half of 2026. Awiqli® is now accepted within the US, EU, and 13 extra nations, with market-specific indications for diabetes.