The FDA has approved Eli Lilly’s Onswik, or insulin efsitora alfa-gobe, as a once-weekly basal insulin for adults with type 2 diabetes.
Onswik is indicated alongside diet and exercise to improve blood-sugar control. The long-acting injection is designed to provide basal insulin coverage for seven days, reducing the number of injections compared with a once-daily basal insulin regimen.
The approval is based on Lilly’s Phase 3 QWINT clinical program, which enrolled more than 3,400 adults with type 2 diabetes. In each study, once-weekly Onswik met the primary endpoint of noninferior reduction in hemoglobin A1C, a measure of average blood-sugar levels, compared with once-daily insulin glargine U-100 or insulin degludec U-100.
Lilly said Onswik’s overall safety profile in the trials was similar to the daily basal insulins used as comparators.
The medicine should not be used in people with type 1 diabetes because of an increased risk of severe hypoglycemia, or low blood sugar. Reported common side effects include hypoglycemia, allergic reactions, injection-site reactions, lipodystrophy, itching, rash, swelling of the hands and feet, and weight gain.
Onswik will be available in the United States in the coming months through Lilly’s KwikPen device. The company plans to offer two concentrations: 500 units per milliliter, containing 1,500 units per pen, and 1,000 units per milliliter, containing 3,000 units per pen.
The U.S. authorization is the fourth global regulatory approval for Onswik in adults with type 2 diabetes, following decisions by the European Medicines Agency, Mexico’s Federal Commission for Protection Against Sanitary Risks and Japan’s Pharmaceuticals and Medical Devices Agency.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!