FDA greenlights Eli Lilly's weekly insulin injection for adults with type 2 diabetes

Eli Lilly announced that the FDA has approved its once-weekly basal insulin, Onswik (insulin efsitora alfa-gobe), for adults managing type-2 diabetes. The approval follows a pivotal trial program enrolling over 3,400 participants across four studies, where Onswik achieved the primary endpoint of non-inferior A1C reduction compared with daily basal insulins like insulin glargine. Scheduled for U.S. availability in the next few months, the product will be delivered via a pre-filled KwikPen in 500 U/mL and 1,000 U/mL concentrations.

While it can reduce more than 300 injections per year, the label advises against use in type-1 diabetes due to a risk of severe low blood sugar. Onswik has previously secured regulatory clearance in Europe, Japan and Mexico, and joins Novo Nordisk’s recently approved weekly insulin Awiqli as a new option for type-2 diabetes management.