FDA Approves Eli Lilly's Once-Weekly Insulin Injection for Type 2 Diabetes
The new treatment, Onswik, offers patients an alternative to daily injections and could reduce the number of shots by over 300 annually.
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s once-weekly basal insulin injection, Onswik, for adults diagnosed with type 2 diabetes. The drugmaker announced the approval on Thursday, presenting a new option for patients managing their condition.
Onswik, which is chemically known as insulin efsitora alfa-gobe, is designed to work in conjunction with diet and exercise to help control high blood sugar levels. Eli Lilly highlighted that this once-weekly regimen could significantly decrease the number of injections a patient administers, potentially by more than 300 per year, when compared to traditional daily basal insulin treatments.
Eli Lilly stated that Onswik is expected to become available in the United States within the coming months. It will be offered in a pre-filled KwikPen delivery system and will come in two concentrations: 500 units per milliliter and 1,000 units per milliliter.
The FDA's decision was informed by the results of a late-stage clinical trial that included over 3,400 adults with type 2 diabetes across four separate studies. The trial's primary objective was met in each study, demonstrating that Onswik achieved reductions in A1C levels—a key indicator of blood sugar control—that were comparable to, or not inferior to, those achieved with daily basal insulins like insulin glargine.
Insulin glargine, known by brand names such as Sanofi’s Lantus and Eli Lilly’s own Basaglar, is a long-acting synthetic insulin used to manage blood sugar in both type 1 and type 2 diabetes. However, Eli Lilly noted that Onswik is not recommended for patients with type 1 diabetes due to an elevated risk of severe hypoglycemia, or dangerously low blood sugar.
Onswik has previously received regulatory clearance in Europe, Japan, and Mexico. This U.S. approval follows the FDA’s March authorization of Novo Nordisk’s insulin injection, Awiqli, which is also intended for blood sugar control in adults with type 2 diabetes.