The US Food and Drug Administration has approved Eli Lilly’s Onswik, a once-weekly basal insulin for adults with type 2 diabetes, potentially cutting the number of basal-insulin injections from 365 a year to 52.

 

The approval gives patients who require basal insulin a weekly option designed to maintain steady insulin levels over seven days. Lilly said Onswik is intended for use alongside diet and exercise to control high blood sugar.

 

"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," said Kenneth Custer, executive vice president and president, Lilly Cardiometabolic Health. 

 

"Onswik offers a new once-weekly basal insulin option for patients and reflects our continued commitment to deliver innovative treatment options that expand choice and provide greater flexibility in how people manage type 2 diabetes."

 

The FDA decision is based on Lilly’s QWINT Phase 3 clinical program, which included more than 3,400 adults with type 2 diabetes across four trials. In each study, once-weekly Onswik met its primary objective of demonstrating non-inferior A1C reduction compared with established daily basal insulins — insulin glargine U-100 or insulin degludec U-100.

 

The trials covered patients who had not previously used insulin as well as those already receiving basal insulin and patients using multiple daily injections of mealtime insulin.

 

Lilly said Onswik showed an overall safety profile similar to the daily basal insulins studied in the trials. The most common side effects included hypoglycemia, allergic reactions, injection-site reactions, lipodystrophy, itching, rash, swelling of the hands and feet, and weight gain.

 

The drug is not approved for people with type 1 diabetes, because of an increased risk of severe hypoglycemia.

 

The FDA approval is the fourth regulatory authorization for Onswik. It follows approvals from the European Medicines Agency, Mexico’s Federal Commission for the Protection against Sanitary Risks and Japan’s Pharmaceuticals and Medical Devices Agency.

 

Lilly plans to make the Onswik KwikPen available in the United States in the coming months in two concentrations: 500 units/mL and 1,000 units/mL.

 

The once-weekly formulation comes as diabetes continues to affect a large and growing population. Lilly cited estimates that roughly one in eight Americans lives with diabetes, with most having type 2 diabetes. Globally, more than 510 million people are expected to have diabetes by 2030, with about 38 million expected to use insulin.

 

For patients prescribed Onswik, the treatment is administered once a week on the same day each week. The FDA-approved labeling includes specific instructions for changing the injection day and handling missed doses.