- Eli Lilly received FDA approval for Onswik, a once-weekly basal insulin for adults with type 2 diabetes
- Onswik improves blood sugar control alongside diet and exercise
- Approval was based on Lilly's QWINT Phase 3 trials involving over 3,400 adults with type 2 diabetes
Eli Lilly has secured US Food and Drug Administration approval for Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for adults with type 2 diabetes, adding a dosing option to its diabetes portfolio.
The approval covers Onswik for use alongside diet and exercise to improve blood sugar control. Lilly said the treatment is designed to provide basal insulin coverage across seven days, reducing injections compared with once-daily basal insulin.
According to PR Newswire reports, the FDA decision is supported by Lilly's QWINT Phase 3 programme, which involved more than 3,400 adults with type 2 diabetes across four registration trials.
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In the studies, once-weekly Onswik achieved non-inferior reductions in A1C compared with daily insulin glargine U-100 or insulin degludec U-100. Lilly said its overall safety profile was similar to the daily basal insulins evaluated.
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Onswik is the fourth global regulatory approval for the treatment, following actions by the European Medicines Agency, Mexico's COFEPRIS and Japan's Pharmaceuticals and Medical Devices Agency.
The product will be sold in the US as the Onswik KwikPen in two concentrations, 500 units/mL and 1,000 units/mL, with launch expected in coming months.
Lilly said the drug is intended only for adults with type 2 diabetes and should not be used by people with type 1 diabetes because of the risk of severe hypoglycemia.
Common side effects include low blood sugar, injection-site reactions, allergic reactions, itching, rash, swelling of the hands and feet and weight gain.
Onswik expands the diabetes portfolio, which includes insulin, incretin-based treatments and oral and injectable medicines.
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The approval comes as insulin remains important for many people with type 2 diabetes who do not achieve blood sugar goals with other therapies. Lilly said the weekly format could reduce injections while maintaining blood sugar control.
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