Adults with type 2 diabetes who currently jab themselves with insulin every single day now have a new option that requires just one injection a week. The U.S. Food and Drug Administration has approved Eli Lilly's Onswik, a basal insulin designed to be used alongside diet and exercise to help control high blood sugar, cutting what could be more than 300 annual injections down to a fraction of that.
Onswik, chemically known as insulin efsitora alfa-gobe, won its FDA approval Thursday for adults with type 2 diabetes, according to Reuters. Compared with once-daily basal insulin, the outlet reports the weekly shot could reduce the number of injections by more than 300 per year. As FOX 10 Phoenix notes, the drug will be dispensed through a pre-filled disposable KwikPen.
How the Weekly Dose Compares to Daily Shots
The approval rests on a late-stage trial program that enrolled more than 3,400 adults with type 2 diabetes across four studies, per the same Reuters report. Across those trials, known as the QWINT program, Onswik produced A1C reductions that were non-inferior to the daily basal insulins glargine and degludec, the outlet reports. Eli Lilly confirms the trials met their primary endpoint of non-inferior A1C reduction against both comparators.
Across the QWINT studies, efsitora achieved A1C reductions comparable to daily basal insulins, with a weekly rather than daily injection schedule.
Two Concentrations, One Weekly Schedule
Lilly expects Onswik to reach U.S. pharmacies in the coming months, arriving as a pre-filled KwikPen in two concentrations: 500 units per milliliter and 1,000 units per milliliter, according to Reuters. HCPLive reports the injection is given subcutaneously once weekly, on the same day each week, giving patients a fixed routine rather than a daily one.
The drug is not intended for everyone with diabetes. Onswik should not be used by people with type 1 diabetes because of an increased risk of severe hypoglycemia, Reuters reports. The overall safety profile in trials was otherwise similar to the daily basal insulins studied, according to a statement carried by PR Newswire.
Lilly Frames the Approval as Easing a Daily Burden
Kenneth Custer, Lilly's executive vice president and president of Lilly Cardiometabolic Health, said delays in initiating treatment and the burden of daily injections can have a real impact on patients' day-to-day experience managing type 2 diabetes, per the PR Newswire statement. FOX 10 Phoenix reports Custer also said the once-weekly treatment expands choice and provides greater flexibility in managing diabetes.
Onswik is not entirely new to the global market. The drug had previously received regulatory approvals in Europe, Japan and Mexico before Thursday's FDA clearance, Reuters reports, and Lilly's approval history for the drug spans four regulatory bodies. Eli Lilly's news release also notes that this is the same weekly insulin studied under the QWINT trial name mentioned across the clinical literature.
A Diabetes Population That Keeps Growing
Lilly's release states that around one in eight Americans live with diabetes, and most of them have type 2 diabetes. Globally, the same release projects that by 2030 more than 510 million people are expected to live with the disease, with an estimated 38 million of them using insulin.
Onswik is not yet available in the U.S.; Lilly expects it to reach pharmacies in the coming months. In March, the FDA approved Novo Nordisk's insulin injection Awiqli for adults with type 2 diabetes, Reuters reports.
