FDA Approves Eli Lilly’s Once-Weekly Insulin for Type 2 Diabetes

This regulatory milestone follows a series of global approvals for the drug, known chemically as insulin efsitora alfa-gobe, including clearances from health authorities in the European Union, Mexico, and Japan. The FDA decision stems from the QWINT clinical trial program, which monitored more than 3,400 participants to confirm that the once-weekly regimen achieves glycemic control comparable to existing daily basal insulins, such as insulin glargine and insulin degludec.

Kenneth Custer, executive vice president at Lilly Cardiometabolic Health, noted that the medication addresses the persistent challenge of treatment initiation and the physical toll of frequent injections. While the drug offers new flexibility for patients, the company emphasized that it is not indicated for individuals with type 1 diabetes due to the risk of severe hypoglycemia. The Onswik KwikPen is expected to reach the U.S. market in the coming months, available in 500 units/mL and 1,000 units/mL concentrations.