FDA approves Eli Lilly’s once-a-week insulin injection for type 2 diabetes treatment

Adults with type 2 diabetes will have a new alternative to daily insulin injections now that the U.S. Food and Drug Administration (FDA) approved a new once-a-week insulin injection. 

The drug’s maker, Eli Lilly, said Thursday federal regulators gave their approval for Onswik, a basal insulin injection. 

What we know:

Onswik, chemically known as insulin efsitora alfa-gobe, is designed to be used along with diet and exercise in patients to control high blood sugar. Eli Lilly says the weekly injection could reduce by more than 300 the number of annual shots those who depend on insulin injections would require.

What they’re saying:

Kenneth Custer, Ph.D., the executive vice president and president of Lilly Cardiometabolic Health, said the once-weekly treatment option expands choice and provides greater flexibility in managing the disease.

“For over a century, Lilly has been developing insulins that transformed diabetes care for millions of people worldwide, but delays in initiating treatment and the burden of daily injections can have a real impact on patients’ day-to-day experience managing type 2 diabetes,” Custer said.

Dig deeper:

The FDA’s approval marks the fourth global approval for Onswik for adults with type 2 diabetes, Lilly said in a release. The medication also received approval from the European Medicines Agency, Mexico’s Federal Commission for the Protection against Sanitary Risks and Japan’s Pharmaceuticals and Medical Devices Agency.

The FDA based its approval on data from a trial involving more than 3,400 adults. When researchers compared patients’ A1C, a measure of blood sugar levels, they found those using Onswik had a similar reduction in A1C over seven days to those on daily insulin injections, the company said. 

The study also found that Onswik demonstrated an overall safety profile similar to the daily basal insulin doses.

Approximately one in eight Americans live with diabetes and most of them have type 2 diabetes. Experts suggest that by 2030, over 510 million people around the world are expected to have the disease. Of those, 38 million are expected to use insulin. 

What to Know:

It is dispensed through a pre-filled injectable KwikPen, a disposable injector similar to those used with GLP-1 weight management medications like Mounjaro, which Lilly also manufactures.

Eli Lilly said the drug is not designed to be used by those with type 1 diabetes because it could cause an increased risk of severe hypoglycemia, or low blood sugar. 

Common side effects include low blood sugar, allergic reactions, reactions at the injection site, skin thickening or pits at the injection site, itching, rash, swelling of hands and feet, and weight gain. 

The KwikPen will be available in the U.S. in the coming months in two concentrations, the company said.