Key facts
- The US FDA approved Eli Lilly's once-weekly basal insulin, Onswik, for adults with type 2 diabetes.
- Onswik, chemically known as insulin efsitora alfa-gobe, is intended for use alongside diet and exercise.
- The once-weekly treatment could reduce the number of injections by more than 300 per year compared to daily basal insulin.
- Onswik will be available in the US in the coming months as a pre-filled KwikPen in two concentrations.
- The approval was based on a late-stage trial of over 3,400 adults with type 2 diabetes.
- Onswik met its main goal in trials, showing reductions in A1C comparable to daily basal insulins like glargine.
The US Food and Drug Administration has approved Eli Lilly's once-weekly basal insulin, Onswik, for adults with type 2 diabetes, offering patients an alternative to daily long-acting insulin injections. The drug, chemically known as insulin efsitora alfa-gobe, is designed to be used in conjunction with diet and exercise to manage high blood sugar levels.
Lilly stated that Onswik could potentially reduce the number of annual injections by over 300 compared to daily basal insulin regimens. The pre-filled KwikPen formulation will be available in the United States in the coming months in two concentrations: 500 units per milliliter and 1,000 units per milliliter.
The approval was supported by data from four late-stage studies involving more than 3,400 adults with type 2 diabetes. These studies demonstrated that Onswik met its primary goal by achieving A1C reductions that were not inferior to those seen with daily basal insulins such as glargine. Insulin glargine, marketed under brands like Sanofi's Lantus and Lilly's Basaglar, is a long-acting insulin used for blood sugar control in both type 1 and type 2 diabetes.
Lilly advised that Onswik should not be administered to patients with type 1 diabetes due to an elevated risk of severe hypoglycemia. The drug has previously secured regulatory approvals in Europe, Japan, and Mexico. In March, the US FDA also approved Novo Nordisk's insulin injection, Awiqli, for managing blood sugar in adults with type 2 diabetes.