Eli Lilly and Company has received U.S. Food and Drug Administration (FDA) approval for Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin for adults with type 2 diabetes.
Onswik is used alongside diet and exercise to help control blood sugar. The medicine is designed to provide steady basal insulin levels for seven days, offering an alternative to daily basal insulin injections.
Lilly said the approval could give people with type 2 diabetes another option for managing their condition while reducing the frequency of insulin injections.
The FDA decision is supported by results from the QWINT Phase 3 clinical trial program, which included more than 3,400 adults with type 2 diabetes. Across the trials, once-weekly Onswik achieved the main study goal by showing a reduction in A1C that was not inferior to daily insulin glargine U-100 or insulin degludec U-100.
The safety profile of Onswik was generally similar to the daily basal insulins evaluated in the trials. Reported side effects included low blood sugar, allergic reactions, injection-site reactions, skin changes at the injection site, itching, rash, swelling of the hands and feet, and weight gain.
Onswik is not indicated for people with type 1 diabetes because of the risk of severe hypoglycemia.
The U.S. approval marks the fourth regulatory approval for Onswik worldwide. The medicine has previously received regulatory 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 launch Onswik in the U.S. in the coming months through its Onswik KwikPen. The product will be available in two concentrations: 500 units/mL, containing 1,500 units in total, and 1,000 units/mL, containing 3,000 units.
The approval comes as insulin remains an important treatment for many people with type 2 diabetes who do not reach their blood sugar goals with other medicines. Lilly said Onswik adds another option for patients seeking more flexibility in their insulin treatment routine.