FDA Approves Eli Lilly's Once-Weekly Insulin Onswik for Type 2 Diabetes

The U.S. Food and Drug Administration (FDA) on Thursday approved Eli Lilly’s once-weekly basal insulin injection, Onswik, for adults with type 2 diabetes. The new treatment is designed to control high blood sugar in conjunction with diet and exercise, providing an alternative to daily long-acting insulin shots.

According to the drugmaker, the shift to a once-weekly schedule could reduce the number of injections for a patient by more than 300 per year compared to a daily basal insulin regimen. Eli Lilly stated that Onswik will be available in the United States in the coming months in a pre-filled KwikPen.

Clinical Trial Backing

The regulatory green light was based on data from a late-stage clinical trial program that involved more than 3,400 adults with type 2 diabetes across four separate studies. In each study, Onswik successfully met its primary endpoint.

The results demonstrated that the once-weekly injection was not inferior to daily basal insulins, such as insulin glargine, in reducing A1C levels, a key measure of a person's average blood sugar over time. Insulin glargine is the active ingredient in widely used treatments like Sanofi’s Lantus and Lilly’s own Basaglar.

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Market Context and Limitations

This approval positions Eli Lilly to compete more directly with Novo Nordisk, whose own once-weekly insulin injection, Awiqli, was approved by the FDA in March for adults with type 2 diabetes. Onswik, known chemically as insulin efsitora alfa-gobe, has already received regulatory approval in other major markets, including Europe, Japan, and Mexico.

Lilly specified that Onswik is not intended for use in patients with type 1 diabetes. The company noted an increased risk of severe hypoglycemia, or dangerously low blood sugar, for this patient group.