FDA approves insulin icodec (Avikli) 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, once-weekly injections have been approved in type 2 diabetes as an adjunct to diet and exercise. Patients are given 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 included four randomized, treatment-to-target trials. Approximately 2,680 adults with uncontrolled type 2 diabetes were enrolled in the program using insulin icodec alone with mealtime insulin or in combination with usual oral antidiabetic agents and/or GLP-1 receptor agonists.
In Follow-up 1, participants had a greater mean 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 versus 0.16 events per person-year).
This approval comes after a regulatory journey of almost 3 years.
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 further 6 testsThe once-weekly injection showed no inferiority to once-daily insulin degludec for HbA1c reduction in the type 1 population, but the predicted rate of severe or clinically significant hypoglycemia was significantly higher.
Ultimately, the committee determined that the risk-benefit profile was unfavorable for type 1 diabetes, and in July 2024, FDA rejected Insulin icodec over these safety concerns as well as concerns related to manufacturing.
Novo Nordisk expects to launch Icodec, a once-weekly insulin for type 2 diabetes, in the second half of this year.
