FDA approves Onswik as once-weekly insulin for type 2 diabetes

The FDA approved Eli Lilly’s Onswik (insulin efsitora alfa-gobe) as an add-on to diet and exercise to improve blood sugar control in adults with type 2 diabetes. The under-the-skin injection is given once weekly on the same day each week. It is the second once-weekly insulin approved for this group.

The FDA said four randomized studies found Onswik reduced HbA1c, a measure of average blood sugar over time, to a similar extent as insulin glargine and insulin degludec. The FDA does not recommend Onswik for people with type 1 diabetes because of the risk of severe low blood sugar. Common adverse reactions include low blood sugar, allergic reactions, injection-site reactions, itching, rash, swelling and weight gain. Lilly said its Onswik KwikPen will be available in the U.S. in the coming months in 500 U/mL and 1,000 U/mL doses.