Eli Lilly's Onswik receives FDA approval for weekly type 2 diabetes treatment

The U.S. Food and Drug Administration (FDA) has approved Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for adults with type 2 diabetes. Developed by Eli Lilly, the medication aims to reduce the burden of daily injections, potentially saving patients over 300 shots per year.

Clinical data from the QWINT program demonstrated that efsitora met noninferiority endpoints for HbA1c reduction compared to once-daily glargine U-100 or degludec U-100. In insulin-naive adults, a fixed-dose regimen was associated with a 43% reduction in the rate of clinically significant or severe hypoglycemia compared to glargine, which researchers attributed to a flatter pharmacokinetic profile.

Onswik has already received regulatory approvals in other regions, including Japan, Mexico, and the European Union. Dosing involves a specific titration schedule, which may include a loading dose to reach steady state more quickly, given the drug's approximately 17-day half-life.