WASHINGTON: The U.S. Food and Drug Administration has approved Eli Lilly’s once-weekly basal insulin for adults with type 2 diabetes, giving patients an alternative to daily long-acting insulin injections.
Lilly said its Onswik, chemically known as insulin efsitora alfa-globe, is indicated alongside diet and exercise to help control high blood sugar.
The company said the once-weekly treatment could reduce the injection burden by more than 300 injections a year compared with once-daily basal insulin.
Onswik is expected to become available in the United States in the coming months as a prefilled KwikPen in concentrations of 500 units per milliliter and 1,000 units per milliliter.
The FDA approval was based on four clinical trials involving more than 3,400 adults with type 2 diabetes. Onswik met the primary objective in each study, producing reductions in A1C, a measure of average blood sugar levels, that were not inferior to those achieved with daily insulin glargine.
Insulin glargine is used to control blood sugar in people with type 1 and type 2 diabetes and is sold under brands including Sanofi’s Lantus and Lilly’s Basaglar.
Lilly said Onswik has previously received regulatory clearance in Europe, Japan and Mexico.