Eli Lilly received FDA approval Sept. 24 for Onswik, a once-weekly basal insulin injection for adults with Type 2 diabetes.
The FDA approved Onswik for use alongside diet and exercise to improve glycemic control. The drug delivers steady basal insulin levels over seven days. Lilly said the drug is designed to eliminate more than 300 injections per year compared with once-daily basal insulin.
The approval rests on Lilly’s phase 3 QWINT program, which enrolled more than 3,400 adults with Type 2 diabetes across four global registration studies. In every trial, Onswik met its primary endpoint: A1C reduction that was noninferior to daily insulin glargine U-100 or insulin degludec U-100. Its safety profile was similar to that of the daily basal insulins studied.
Onswik is not indicated for Type 1 diabetes because it raises the risk of severe hypoglycemia in those patients.
Lilly plans to launch the Onswik KwikPen in the U.S. in the coming months in two concentrations: 500 units/mL and 1,000 units/mL. The company did not disclose pricing.
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