FDA Approves Weekly Insulin for Type 2 Diabetes

The FDA has approved Onswik (insulin efsitora alfa gobe), a long acting insulin analog given by subcutaneous injection once a week, according to an FDA announcement. It is approved as an add on to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, and it is the second once weekly insulin to reach approval for this population. It is not recommended for people with type 1 diabetes because of a higher risk of severe hypoglycemia.

Approval rests on four randomized, open label, active controlled trials that enrolled adults across a range of prior insulin experience, including people new to insulin and those already on basal or basal plus mealtime regimens. Onswik was compared against once daily insulin glargine or insulin degludec while participants kept their other diabetes medications unchanged. Across the four studies, Onswik lowered hemoglobin A1c to a similar degree as the daily comparators.

The most common adverse reactions were hypoglycemia, injection site reactions, allergic reactions, itching, rash, swelling, and weight gain. The label also carries warnings about medication errors, accidental overdose, low potassium, and fluid retention or heart failure risk when combined with certain other drugs. Full prescribing details are in the FDA announcement linked above.

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