Onswik is indicated in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Rather than requiring a basal insulin injection every day, the medication is formulated to maintain basal insulin levels throughout a seven-day dosing interval.

The FDA decision was supported by Lilly’s Phase 3 QWINT clinical development program, which evaluated more than 3,400 adults with type 2 diabetes across four registration studies. Across the QWINT trials, Onswik met the primary efficacy endpoint, demonstrating A1C reductions that were noninferior to the daily basal insulin comparators insulin glargine U-100 or insulin degludec U-100.

Safety findings were generally consistent with those observed with the daily basal insulins included in the studies. Reported common adverse effects associated with Onswik include hypoglycemia, allergic and injection-site reactions, itching, rash, swelling of the hands and feet, weight gain and lipodystrophy at the injection site. The treatment is not recommended for people with type 1 diabetes because of an increased risk of severe hypoglycemia.

The U.S. authorization marks the fourth global regulatory approval for Onswik in adults with type 2 diabetes, following regulatory actions in Europe, Mexico and Japan. In the United States, Onswik will be offered through the KwikPen delivery system in concentrations of 500 units/mL and 1,000 units/mL.

For patients who require basal insulin, the weekly dosing schedule could substantially reduce the number of injections involved in treatment. Lilly estimates that moving from daily basal insulin to once-weekly Onswik could reduce basal insulin injections from approximately 365 to 52 per year, although the company notes that this calculation is not intended as a comparison of the treatments’ safety or efficacy.

The approval adds a weekly basal insulin to Lilly’s type 2 diabetes treatment portfolio and provides clinicians with another option when considering insulin therapy for appropriate adult patients.