The FDA approved Lilly's weekly Onswik insulin for adults with type 2 diabetes, the company said. Lilly says it offers an alternative to daily long-acting injections that could cut more than 300 shots a year; Lilly expects US availability in coming months.
Approval was based on four late-stage studies involving more than 3,400 adults. Onswik met each study's main goal, with A1C reductions—a measure of blood sugar—that were not inferior to those from daily basal insulin glargine.
Lilly says Onswik is intended for use alongside diet and exercise. It should not be used by people with type 1 diabetes because of an increased risk of severe hypoglycemia, or dangerously low blood sugar. The prefilled KwikPen will come in concentrations of 500 and 1,000 units per milliliter.
