Onswik cleared as once-weekly insulin for type 2 diabetes

Action

The U.S. Food and Drug Administration has approved Onswik (insulin efsitora alfa-gobe) injection, a long-acting insulin analog, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Onswik is administered by subcutaneous (under the skin) injection once weekly on the same day each week. It is not recommended for patients with type 1 diabetes mellitus because of an increased risk of severe hypoglycemia (low blood sugar). Onswik is the second once-weekly insulin to be approved for adults with type 2 diabetes mellitus.

Disease or Condition

Type 2 diabetes mellitus is a chronic disease in which blood glucose (blood sugar) levels are too high because the body does not make enough insulin or does not use insulin effectively. Insulin helps regulate blood glucose by helping glucose move from the blood into cells and by reducing the amount of glucose produced by the liver. Onswik is a long-acting insulin analog designed to lower blood glucose over a weekly dosing interval.

Effectiveness

The effectiveness of Onswik was evaluated in four randomized, open-label, active-controlled studies in adults with type 2 diabetes mellitus. The studies included adults who had not previously used insulin, adults previously treated with once- or twice-daily basal insulin, and adults previously treated with basal and mealtime insulin. Onswik was administered once weekly and compared with once-daily insulin glargine or insulin degludec. Participants maintained their other diabetes treatments throughout the trial, including mealtime insulin.

In the four studies, Onswik reduced hemoglobin A1c, a measure of average blood glucose over time, to a similar extent compared to insulin glargine and insulin degludec.

Safety Information

The most common adverse reactions associated with Onswik include hypoglycemia, hypersensitivity (allergic) reactions, injection site reactions, lipodystrophy (changes in fat tissue at the injection site), pruritus (itching), rash, edema (swelling), and weight gain.

Hypoglycemia is the most common adverse reaction associated with insulin, including Onswik, and severe hypoglycemia can cause seizures, unconsciousness, life-threatening complications, or death. The labeling for Onswik also includes warnings and precautions for medication errors and accidental overdose, hypersensitivity reactions, hypokalemia (low potassium levels), and fluid retention and heart failure when used with certain medications.

See the full prescribing information for all risks associated with Onswik.