First Once-Weekly Basal Insulin Approved for Type 2 Diabetes

The FDA approved insulin icodec (Awiqli) as the first once-weekly, long-acting basal insulin for glycemic control in adults with type 2 diabetes, developer Novo Nordisk announced.

Of note, the agency rejected the product in 2024 for type 1 diabetes, where it is still not indicated.

Designed to reduce treatment burden as an alternative to daily basal insulin, the once-weekly injection is approved in type 2 diabetes as an adjunct to diet and exercise. Patients administer the dose on the same day each week, with or without food, using a pre-filled FlexTouch device.

The approval is supported by the phase IIIa ONWARDS clinical program, which was comprised of four randomized, treat-to-target trials. Roughly 2,680 adults with uncontrolled type 2 diabetes were enrolled across the program, using insulin icodec with either mealtime insulin or in combination with common oral anti-diabetic agents and/or GLP-1 receptor agonists.

In ONWARDS 1, participants had a greater average reduction in HbA1c with insulin icodec compared with once-daily insulin glargine U100 over 52 weeks (estimated between-group difference -0.19%, 95% CI -0.36 to -0.03). While the rate of clinically significant or severe hypoglycemia was low, it was numerically higher with insulin icodec compared with glargine U100 at week 52 (0.30 vs 0.16 events per person-year).

The approval follows a nearly 3-year regulatory journey.

Safety concerns regarding hypoglycemia previously prompted an FDA advisory committee to convene in May 2024 to discuss the use of icodec in patients with type 1 diabetes. In the ONWARDS 6 trial, the once-weekly injection showed non-inferiority to once-daily insulin degludec for HbA1c reduction in the type 1 population, but carried a significantly higher estimated rate of severe or clinically significant hypoglycemia.

Ultimately, the committee determined the risk-benefit profile was unfavorable for type 1 diabetes, and in July 2024, the FDA rejected insulin icodec over these safety concerns, as well as ones related to manufacturing.

Novo Nordisk expects to launch once-weekly insulin icodec for type 2 diabetes in the second half of this year.