FDA approves Lilly’s once-weekly insulin for adults with type 2 diabetes

The FDA approved Eli Lilly’s Onswik, a long-acting insulin injection for adults with type 2 diabetes, to improve blood sugar control as an addition to diet and exercise. The injection is given under the skin once weekly on the same day each week. The FDA said it is the second once-weekly insulin approved for adults with type 2 diabetes.

The FDA said four studies found that Onswik lowered hemoglobin A1c, a measure of average blood glucose over time, to a similar extent as insulin glargine or insulin degludec. The studies included adults who had not previously used insulin and adults using basal insulin, with or without mealtime insulin. The FDA does not recommend Onswik for people with type 1 diabetes because of increased risk of severe hypoglycemia. Common adverse reactions include hypoglycemia, allergic reactions, injection site reactions, itching, rash, swelling and weight gain.