The FDA approved Eli Lilly's once-weekly insulin Onswik for adults with type 2 diabetes. Lilly said it could reduce injections by more than 300 per year compared with daily basal insulin and will be available in the U.S. in the coming months.
The FDA approved Eli Lilly's once-weekly basal insulin Onswik for adults with type 2 diabetes, the drugmaker said. Lilly expects the treatment to be available in the United States in the coming months as a pre-filled KwikPen in concentrations of 500 and 1,000 units per milliliter.
Approval was based on four late-stage studies involving more than 3,400 adults with type 2 diabetes. Onswik met the main goal in each study, with A1C reductions that were not inferior to daily basal insulin glargine. Lilly said Onswik should not be used by people with type 1 diabetes because of an increased risk of severe hypoglycemia.
Lilly said Onswik could reduce the number of injections by more than 300 per year compared with once-daily basal insulin. The drug has also received regulatory approvals in Europe, Japan and Mexico.