The US Food and Drug Administration has approved Eli Lilly’s once-weekly basal insulin, Onswik, for adults with type 2 diabetes, the drugmaker said on Thursday, offering patients an alternative to daily long-acting insulin injections.
Onswik, chemically known as insulin efsitora alfa-gobe, is intended to be used alongside diet and exercise to control high blood sugar.
The once-weekly treatment could reduce the number of injections by more than 300 per year compared with once-daily basal insulin, Lilly said.
Lilly said Onswik would be available in the United States in the coming months as a pre-filled KwikPen in two concentrations – 500 units per milliliter and 1,000 units per milliliter.
The regulatory approval was based on a late-stage trial, which enrolled more than 3,400 adults with type 2 diabetes across four studies.
Onswik met the main goal in each study, showing reductions in A1C, a measure of blood sugar, that were not inferior to the daily basal insulins glargine.
Insulin glargine, sold under brands such as Sanofi’s Lantus and Lilly’s Basaglar, is a long-acting, man-made insulin used to control blood sugar in type 1 and type 2 diabetes patients.
Lilly said Onswik should not be used in patients with type 1 diabetes because of an increased risk of severe hypoglycemia, or dangerously low blood sugar.
Onswik has previously received regulatory approvals in Europe, Japan and Mexico.
In March, US FDA approved Novo Nordisk’s insulin injection, Awiqli, to control blood sugar levels in adults living with type 2 diabetes.