Novo Nordisk Receives FDA Approval for Awiqli®, a Once-Weekly Basal Insulin for Type 2 Diabetes
Novo Nordisk has announced that the US Food and Drug Administration (FDA) has approved Awiqli® (insulin icodec-abae) injection 700 units/mL, the first once-weekly, long-acting basal insulin for adults with type 2 diabetes.
The treatment is indicated as an adjunct to diet and exercise to improve blood sugar control. This approval introduces the only once-weekly basal insulin option, offering greater flexibility and convenience for patients.
The approval is based on data from the ONWARDS phase 3a programme, which included four randomised, active-controlled trials involving around 2,680 adults with uncontrolled type 2 diabetes.
Participants received Awiqli® either alongside mealtime insulin or in combination with common oral anti-diabetic medications and/or GLP-1 receptor agonists.
The studies showed that once-weekly Awiqli® achieved similar reductions in HbA1c to daily basal insulin while maintaining a comparable safety profile.
Common side effects observed included low blood sugar (hypoglycaemia), injection-site reactions, skin changes at the injection site (lipodystrophy), itching, rash, swelling, and weight gain. Serious allergic reactions were rare. Overall, safety was consistent with the basal insulin class.
Awiqli® provides an alternative to daily injections, which may help some adults with type 2 diabetes adhere to their treatment and better manage their blood sugar.
