A weekly insulin shot could mean more than 300 fewer injections a year for some adults with Type 2 diabetes after the U.S. Food and Drug Administration approved Eli Lilly’s Onswik, offering an alternative to daily long-acting insulin, the company said.
The FDA approved Onswik, for use with diet and exercise to help control high blood sugar in adults with Type 2 diabetes. The drug is designed to provide basal insulin coverage for seven days with one injection.
Lilly said Onswik could reduce the number of injections by more than 300 per year compared with once-daily basal insulin. The company said the treatment is expected to be available in the United States in the coming months through a prefilled KwikPen in 500 units per milliliter and 1,000 units per milliliter strengths.
The approval was supported by Lilly’s QWINT Phase 3 clinical program, which involved more than 3,400 adults. In each study, Onswik met its primary goal by reducing A1C, a measure of average blood sugar, by an amount that was not inferior to daily basal insulin treatments.
The FDA said Onswik was evaluated in four randomized studies involving adults who had not previously used insulin as well as patients who were already receiving basal insulin. The weekly treatment was compared with daily insulin glargine.
Insulin glargine is a long-acting insulin sold under brands including Sanofi’s Lantus and Lilly’s Basaglar. It is used to control blood sugar in people with diabetes.
However, Onswik is not approved for people with Type 1 diabetes because of an increased risk of severe hypoglycemia known as dangerously low blood sugar, the FDA said.
Common side effects include low blood sugar, allergic reactions, injection-site reactions, itching, rash, swelling and weight gain. Onswik had already received regulatory approvals in Europe, Japan and Mexico before the U.S. decision.
