The FDA has approved Eli Lilly’s Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin for adults with type 2 diabetes, to be used with diet and exercise. Approval was based on the Phase III QWINT programme of four trials with >3,400 participants, in which Onswik achieved non-inferior A1C reductions versus daily insulin glargine U-100 or insulin degludec U-100. Pooled safety data were similar to daily basal insulins; common adverse events included injection-site reactions, hypoglycaemia and weight gain. Lilly plans a US KwikPen launch in the coming months in 500 units/mL (1,500-unit) and 1,000 units/mL (3,000-unit) formats.
FDA Approves Lilly’s Once-Weekly Basal Insulin Onswik for Adults With Type 2 Diabetes
The QWINT Phase III study enrolled more than 3
The US Food and Drug Administration (FDA) has approved Eli Lilly and Company’s Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for adults with type 2 diabetes (T2D). Onswik is authorised as an adjunct to diet and exercise and is designed to provide steady basal insulin coverage for seven days with a single weekly dose.
Clinical Evidence
The FDA decision was supported by Lilly’s QWINT Phase III programme, which enrolled more than 3,400 adults with T2D across four pivotal registration trials. In each trial, once-weekly Onswik met its primary endpoint, demonstrating non-inferior reductions in A1C from baseline compared with daily insulin glargine U-100 or insulin degludec U-100.
The QWINT programme evaluated both insulin-naive patients and patients already treated with basal insulin, broadening the generalisability of the results. Trial enrollment by study:
- QWINT-1: 795 participants (Argentina, Mexico, US)
- QWINT-2: 928 participants (Brazil, Canada, China, Czechia, Germany, Greece, Korea, Japan, Mexico, Puerto Rico, US)
- QWINT-3: 986 participants (Argentina, Hungary, Japan, Korea, Poland, Puerto Rico, Slovakia, Spain, Taiwan, US)
- QWINT-4: 730 participants (Argentina, Germany, India, Italy, Mexico, Puerto Rico, Spain, US) — this trial also included insulin lispro in comparison groups
Safety And Side Effects
Lilly reported that pooled data from the QWINT trials showed an overall safety profile for Onswik similar to that of the daily basal insulins assessed. Commonly reported adverse effects included allergic reactions, injection-site reactions, itching (pruritus), lipodystrophy, hypoglycaemia, rash, peripheral swelling (edema), and weight gain.
Availability And Regulatory Status
Lilly plans to make the Onswik KwikPen available in the US in the coming months. It will be offered in two strengths: 500 units/mL pens containing 1,500 units and 1,000 units/mL pens containing 3,000 units.
This FDA approval marks the fourth regulatory authorization for Onswik in adults with T2D, following approvals by the European Medicines Agency (EMA), Mexico’s Federal Commission for the Protection Against Sanitary Risks, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
Kenneth Custer, Lilly executive vice-president and president of cardiometabolic health, said the approval offers patients a once-weekly basal insulin that may reduce the burden of daily injections and expand treatment options for people managing type 2 diabetes.
Separately, Eli Lilly recently announced a five-drug research and licensing partnership with China-based InnoCare Pharma.
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