The FDA has approved once-weekly insulin icodec-abae (Awiqli; Novo Nordisk) for use in adults with type 2 diabetes (T2D), with a current projected launch in the second half of 20,261 for the 700-units/mL dose. This novel treatment option is a first-in-its-class therapeutic, freeing patients living with T2D from their strict schedule of daily basal insulin injections and reducing total injections from 7 to 1 for each 7-day period.

Its indication is as an adjunct to diet and exercise for improved glycemic control, as well as for patients also taking mealtime insulin or another common oral antidiabetic agent and/or a glucagon-like peptide-1 receptor agonist. A prescription is required, and administration is with or without food via a prefilled FlexTouch device on the same day each week.

Data from 4 of the trials in the phase 3a ONWARDS program and 2,680 adult patients with uncontrolled T2D support this approval; their primary end point of interest was reduction in hemoglobin A1c. Overall, the ONWARDS program encompasses 6 phase 3a trials and more than 4,000 adults with type 1 diabetes (T1D) or T2D.

Insulin icodec-abae (Awiqli; Novo Nordisk) is now approved for use in the US, Canada, European Union, Switzerland, and 12 other countries.