Novo Nordisk receives US approval for once-weekly basal insulin Awiqli®
Friday, March 27, 2026
Novo Nordisk A/S has received approval from the US Food and Drug Administration for Awiqli® (insulin icodec-abae) 700 units/mL, a once-weekly, long-acting basal insulin for adults with type 2 diabetes. The treatment is indicated as an addition to diet and exercise to help improve blood sugar control.
Awiqli® is the first once-weekly basal insulin approved in the US, offering an alternative to daily insulin regimens and providing greater flexibility for patients.
The approval is based on results from the ONWARDS Phase 3a clinical programme, which included four randomised, active-controlled trials involving around 2,680 adults with uncontrolled type 2 diabetes. The studies evaluated Awiqli® used alongside mealtime insulin or common oral anti-diabetic medicines and GLP-1 receptor agonists.
The programme showed that once-weekly Awiqli® achieved reductions in HbA1c comparable to daily basal insulin. Its safety profile was found to be consistent with the existing basal insulin class.
Novo Nordisk stated that the approval supports its continued focus on advancing diabetes care and expanding treatment options. The company plans to launch Awiqli® in the FlexTouch® device in the US in the second half of 2026. The product has already been approved in the EU and several other countries, with indications varying by market.
Source: globenewswire.com
