Eli Lilly and Company has announced the US Food and Drug Administration (FDA) approval of Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin, indicated along with diet and exercise to control high blood sugar in adults with Type 2 Diabetes (T2D).

Onswik is designed to deliver steady basal insulin levels over a full 7 days.

Kenneth Custer, PhD, Executive Vice President and President, Lilly Cardiometabolic Health, said, "For over a century, Lilly has been developing insulins that transformed diabetes care for millions of people worldwide, but delays in initiating treatment and the burden of daily injections can have a real impact on patients' day-to-day experience managing Type 2 Diabetes. 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."

This is the fourth global approval for Onswik for adults with T2D, following regulatory actions from the European Medicines Agency (EMA), Mexico's Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

The FDA approval is based on data from the QWINT phase 3 clinical trials, which evaluated the safety and efficacy of once-weekly Onswik in more than 3,400 adults with T2D. In each QWINT trial, once-weekly Onswik met the primary endpoint of non-inferior A1C reduction from baseline that was comparable to insulin glargine U-100 (glargine) or insulin degludec U-100 (degludec).

In these clinical trials, Onswik demonstrated an overall safety profile similar to the daily basal insulins studied. Onswik should not be used by people who have Type 1 Diabetes (T1D) due to increased risk of severe hypoglycemia (low blood sugar).

Common side effects of Onswik include low blood sugar, allergic reactions, reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of hands and feet, and weight gain.

Around 1 in 8 Americans live with diabetes, and most of them have type 2 diabetes. Globally, by 2030, more than 510 million people are expected to live with the disease and 38 million of these are expected to use insulin. Insulin remains an important treatment option for many people with T2D who do not achieve glycemic goals with other therapies.

The Onswik KwikPen will be available in the US in the coming months in 2 concentrations: 500 units/mL (contains 1,500 units total) and 1,000 units/mL (contains 3,000 units total).