Eli Lilly receives FDA approval for once-weekly insulin Onswik

Eli Lilly and Company has received FDA approval for Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin designed for adults with type 2 diabetes. The medication is intended to be used alongside diet and exercise to improve glycemic control.

The approval follows the QWINT Phase III clinical program, which involved over 3,400 participants across multiple countries. In these trials, Onswik met primary endpoints by achieving non-inferior reductions in glycated haemoglobin (A1C) compared to daily insulin glargine U-100 or insulin degludec U-100. The once-weekly dosing schedule significantly reduces the frequency of injections from 365 to 52 per year.

Onswik is not recommended for patients with type 1 diabetes due to an increased risk of severe hypoglycemia. Common side effects reported during clinical trials include hypoglycemia, allergic reactions, injection-site reactions, lipodystrophy, itching, rash, swelling, and weight gain. The product will be administered via a KwikPen device, and patients will require training on its proper use.