FDA approves Eli Lilly’s once-weekly insulin injection for type 2 diabetes

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.

The FDA has approved Eli Lilly’s once-weekly basal insulin, Onswik, for adults with type 2 diabetes. REUTERS

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.

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