The US Food and Drug Administration approved insulin efsitora alfa-gobe (Onswik), a once-weekly basal insulin, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, according to a Eli Lilly and Company press release.

The approval was based on the QWINT phase 3 clinical development program, which enrolled more than 3,400 adults with type 2 diabetes across 4 global registration trials. In each trial, once-weekly insulin efsitora alfa-gobe met the primary end point of noninferiority for hemoglobin A1c reduction from baseline compared with once-daily insulin glargine U-100 or insulin degludec U-100.

QWINT-1 and QWINT-2 evaluated insulin-naive adults with type 2 diabetes. QWINT-1 randomized 795 participants to receive once-weekly insulin efsitora alfa-gobe or once-daily insulin glargine for 52 weeks. QWINT-2 randomized 928 participants to receive once-weekly insulin efsitora alfa-gobe or once-daily insulin degludec for 52 weeks.

QWINT-3 randomized 986 adults currently treated with basal insulin to receive once-weekly insulin efsitora alfa-gobe or once-daily insulin degludec. QWINT-4 randomized 730 adults previously treated with basal insulin and at least 2 daily injections of mealtime insulin to receive once-weekly insulin efsitora alfa-gobe or once-daily insulin glargine, both administered with insulin lispro.

Across the trials, the safety findings with insulin efsitora alfa-gobe were comparable to those observed with the once-daily basal insulin comparators. Common adverse reactions include hypoglycemia, allergic reactions, injection-site reactions, lipodystrophy, pruritus, rash, swelling of the hands and feet, and weight gain.

Insulin efsitora alfa-gobe should not be used in patients with type 1 diabetes because of an increased risk of severe hypoglycemia. Serious adverse reactions may include hypoglycemia, severe allergic reactions, and hypokalemia. Concomitant use of thiazolidinediones may cause or worsen heart failure.

Insulin efsitora alfa-gobe is administered subcutaneously once weekly on the same day each week. The prefilled pens will be available in the US in the coming months in concentrations of 500 units/mL and 1,000 units/mL.

Source: Eli Lilly and Company