US FDA approves Lilly's once-weekly insulin injection for type 2 diabetes

By Reuters News

Sept 24 (Reuters) - The US Food and Drug Administration has approved Eli Lilly's LLY.N 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.


Here are some details:

  • 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 NOVOb.CO insulin injection, Awiqli, to ​control blood sugar levels ​in adults living with type ⁠2 diabetes.

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