FDA approves Lilly’s Onswik for type 2 diabetes in adults

This treatment is approved for use alongside diet and exercise to improve blood sugar control. Onswik is intended to provide steady basal insulin levels for seven days.

The FDA decision was supported by Lilly’s QWINT Phase III clinical programme, which enrolled more than 3,400 adults with T2D across four registration trials.

In each trial, once-weekly Onswik met its primary endpoint for non-inferior reductions in A1C from baseline, compared with daily insulin glargine U-100 or insulin degludec U-100.

The programme included patients new to insulin treatment and those already using basal insulin.

QWINT-1 enrolled 795 participants in Argentina, Mexico and the US, while QWINT-2 enrolled 928 people in Brazil, Canada, China, Czechia, Germany, Greece, Korea, Japan, Mexico, Puerto Rico and the US.

QWINT-3 involved 986 participants in Argentina, Hungary, Japan, Korea, Poland, Puerto Rico, Slovakia, Spain, Taiwan and the US. QWINT-4 enrolled 730 participants in Argentina, Germany, India, Italy, Mexico, Puerto Rico, Spain and the US.

The studies compared efsitora with insulin degludec or insulin glargine, with QWINT-4 also using insulin lispro.

Lilly said the trials showed an overall safety profile for Onswik similar to that of the daily basal insulins assessed.

Reported common side effects include allergic reactions, injection-site reactions, itching, lipodystrophy, low blood sugar, rash, swelling of the hands and feet, and weight gain.

Lilly executive vice-president and cardiometabolic health president Kenneth Custer said: “For over a century, Lilly has been developing insulins that transformed diabetes care for millions of people worldwide, but delays in initiating treatment and the burden of daily injections can have a real impact on patients’ day-to-day experience managing T2D.

“Onswik offers a new once-weekly basal insulin option for patients and reflects our continued commitment to deliver innovative treatment options that expand choice and provide greater flexibility in how people manage type 2 diabetes.”

Lilly plans to make the Onswik KwikPen available in the US in the coming months. It will be supplied in 500 units/mL pens containing 1,500 units and 1,000 units/mL pens containing 3,000 units.

The FDA approval is the fourth global approval for Onswik in adults with type 2 diabetes, following regulatory actions by the European Medicines Agency, Mexico’s Federal Commission for the Protection against Sanitary Risks and Japan’s Pharmaceuticals and Medical Devices Agency.

Earlier this week, Eli Lilly partnered with China-based InnoCare Pharma in a five-drug research and licensing agreement.