US FDA clears Eli Lilly's once-weekly insulin Onswik for type 2 diabetes

The US Food and Drug Administration has approved Eli Lilly's once-weekly basal insulin, Onswik, for adults with type 2 diabetes, the drugmaker said, giving patients an alternative to long-acting insulin injections taken every day.

Onswik, whose chemical name is insulin efsitora alfa-gobe, is meant to be used along with diet and exercise to manage high blood sugar. According to Lilly, the weekly dosing schedule could reduce the number of injections by more than 300 a year compared with once-daily basal insulin.

The company said the product would reach the US market in the coming months as a pre-filled KwikPen in two strengths: 500 units per millilitre and 1,000 units per millilitre.

The approval rests on a late-stage programme that enrolled more than 3,400 adults with type 2 diabetes across four studies. Onswik met the primary goal in each trial, delivering reductions in A1C — a measure of blood sugar — that were not inferior to the daily basal insulin glargine.

Glargine, sold under brands including Sanofi's Lantus and Lilly's own Basaglar, is a long-acting, man-made insulin used to control blood sugar in people with type 1 and type 2 diabetes.

Lilly cautioned that Onswik should not be prescribed to patients with type 1 diabetes because of a heightened risk of severe hypoglycaemia, or dangerously low blood sugar.

The drug has already secured regulatory approvals in Europe, Japan and Mexico. Its US clearance follows the FDA's March approval of Novo Nordisk's insulin injection Awiqli for controlling blood sugar levels in adults with type 2 diabetes.