Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration has approved Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection indicated, alongside diet and exercise, to control high blood sugar in adults with type 2 diabetes.

The approval marks the fourth global regulatory clearance for Onswik, following earlier approvals from the European Medicines Agency, Mexico's COFEPRIS, and Japan's Pharmaceuticals and Medical Devices Agency.

The FDA's decision is based on data from the QWINT Phase 3 clinical trial program, which evaluated safety and efficacy in more than 3,400 adults with type 2 diabetes across four studies. In each trial, Onswik met its primary endpoint of non-inferior A1C reduction compared to either insulin glargine U-100 or insulin degludec U-100. The drug's overall safety profile was reported to be similar to those daily basal insulins.

Onswik is not indicated for people with type 1 diabetes due to an increased risk of severe hypoglycemia. Common side effects include low blood sugar, allergic reactions, injection site reactions, lipodystrophy, itching, rash, swelling of the hands and feet, and weight gain.

The Onswik KwikPen will be available in the U.S. in the coming months in two concentrations: 500 units/mL and 1,000 units/mL.

Kenneth Custer, Ph.D., executive vice president and president of Lilly Cardiometabolic Health, said in a statement: "Onswik offers a new once-weekly basal insulin option for patients and reflects our continued commitment to deliver innovative treatment options that expand choice and provide greater flexibility in how people manage type 2 diabetes."

According to the Centers for Disease Control and Prevention, approximately one in eight Americans lives with diabetes, with the majority having type 2 diabetes. The information in this article is based on a press release from Eli Lilly and Company.