FDA Approves Lilly's Onswik, a Once-Weekly Basal Insulin for Type 2 Diabetes

The U.S. Food and Drug Administration has approved Eli Lilly's Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin, along with diet and exercise to control high blood sugar in adults with type 2 diabetes, the company announced on September 24.

Onswik is designed to deliver steady basal insulin levels over a full seven days, Lilly said, and to cut injections by more than 300 a year compared with a once-daily basal insulin. It is the second once-weekly basal insulin the FDA has approved for type 2 diabetes, following Novo Nordisk's Awiqli (insulin icodec-abae) in March, Healio reported.

The QWINT trials

The approval is based on the Phase 3 QWINT program, which began in 2022 and enrolled more than 3,400 adults with type 2 diabetes in four global registration studies. In each trial, once-weekly Onswik met its primary endpoint of non-inferior A1C reduction from baseline compared with daily insulin glargine U-100 or insulin degludec U-100, according to Lilly. The trials were sponsored by the company.

• QWINT-1 randomized 795 adults who had not used insulin before to Onswik or glargine for 52 weeks, using a fixed-dose escalation approach.
• QWINT-2 randomized 928 insulin-naive adults to Onswik or degludec for 52 weeks and also looked at patients using and not using GLP-1 receptor agonists.
• QWINT-3 randomized 986 adults already on basal insulin to Onswik or degludec, with the primary endpoint at week 26.
• QWINT-4 randomized 730 adults on basal insulin and at least two daily mealtime insulin injections to Onswik or glargine, both alongside insulin lispro, for 26 weeks.

Healio reported that in QWINT-3, adults on Onswik had a greater decrease in A1C at one year than those on degludec.

Safety and availability

Across the trials, Onswik showed an overall safety profile similar to the daily basal insulins it was compared with, Lilly said. The company said Onswik should not be used by people with type 1 diabetes because of an increased risk of severe hypoglycemia, and that it is not known whether it is safe and effective in children. Common side effects include low blood sugar, allergic reactions, injection-site reactions, lipodystrophy, itching, rash, swelling of the hands and feet, and weight gain.

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

The Onswik KwikPen will be available in the U.S. in the coming months in two concentrations, 500 units/mL and 1,000 units/mL, according to Lilly. The U.S. decision is the drug's fourth approval worldwide, after the European Medicines Agency, Mexico's COFEPRIS and Japan's Pharmaceuticals and Medical Devices Agency.