FDA Approves Lilly's Onswik, a Once-Weekly Basal Insulin for Type 2 Diabetes
核心洞察
The FDA has approved Onswik (搜索) (insulin efsitora alfa-gobe (搜索)), a once-weekly basal insulin indicated with diet and exercise for adults with type 2 diabetes (搜索).
Approval rests on the QWINT Phase 3 program, in which once-weekly Onswik (搜索) met non-inferior A1C reduction versus daily insulin glargine or degludec in over 3,400 adults.
Onswik (搜索) is Lilly's fourth global approval for the product, following regulatory actions by the EMA, Mexico's COFEPRIS (搜索) and Japan's PMDA.
Eli Lilly and Company has received U.S. Food and Drug Administration (搜索) approval for Onswik (搜索) (insulin efsitora alfa-gobe (搜索)), a once-weekly basal insulin indicated, along with diet and exercise, to control high blood sugar in adults with type 2 diabetes (搜索). Onswik is designed to deliver steady basal insulin levels over a full seven days.
The approval is the fourth global regulatory action for the product in adults with type 2 diabetes (搜索), following decisions by the European Medicines Agency (搜索), Mexico's Federal Commission for the Protection against Sanitary Risks (COFEPRIS (搜索)) and Japan's Pharmaceuticals and Medical Devices Agency (搜索).
"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 type 2 diabetes (搜索)," said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health. "Onswik (搜索) 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."
QWINT Phase 3 Program
The FDA decision is based on data from the QWINT Phase 3 clinical trials, which evaluated the safety and efficacy of once-weekly Onswik (搜索) in more than 3,400 adults with type 2 diabetes (搜索). In each QWINT trial, once-weekly Onswik met the primary endpoint of non-inferior A1C reduction from baseline that was comparable to insulin glargine U-100 or insulin degludec U-100.
The QWINT program began in 2022 and enrolled participants across four global registration studies.
QWINT-1 (NCT05662332) was a parallel-design, open-label, treat-to-target, randomized controlled trial comparing efsitora as a once-weekly basal insulin using fixed-dosage escalation with daily insulin glargine over 52 weeks in insulin-naive adults with type 2 diabetes (搜索). The trial randomized 795 participants across the U.S., Argentina and Mexico to subcutaneous efsitora once weekly or insulin glargine once daily. Participants on efsitora received a starting dose of 100 units, followed by escalation to fixed dosages of 150 units, 250 units and 400 units every four weeks as needed, until achieving a target fasting blood glucose of 80-130 mg/dL. Participants with fasting blood glucose above 130 mg/dL on or after 16 weeks underwent additional weekly dosage adjustments as needed. The primary objective was to demonstrate non-inferiority in reducing A1C at week 52 versus daily insulin glargine.
QWINT-2 (NCT05362058) compared once-weekly efsitora with insulin degludec over 52 weeks in insulin-naive adults with type 2 diabetes (搜索), randomizing 928 participants across the U.S., Brazil, Canada, China, Czechia, Germany, Greece, Japan, Korea, Mexico and Puerto Rico. The primary objective was non-inferiority in A1C reduction at week 52 versus insulin degludec. The trial was also designed to assess efficacy and safety in patients using and not using GLP-1 receptor (搜索) agonists.
QWINT-3 (NCT05275400) was a multicenter, randomized, parallel-design, open-label trial comparing once-weekly efsitora with insulin degludec for 78 weeks after a three-week lead-in and a five-week safety follow-up, in adults with type 2 diabetes (搜索) already treated with basal insulin. It randomized 986 participants across the U.S., Argentina, Hungary, Japan, Korea, Poland, Puerto Rico, Slovakia, Spain and Taiwan. The primary objective was non-inferiority in A1C reduction at week 26 versus insulin degludec.
QWINT-4 (NCT05462756) compared weekly efsitora with insulin glargine over 26 weeks in adults with type 2 diabetes (搜索) previously treated with basal insulin and at least two injections per day of mealtime insulin. The trial randomized 730 participants across the U.S., Argentina, Germany, India, Italy, Mexico, Puerto Rico and Spain to efsitora once weekly or insulin glargine once daily, both administered subcutaneously along with insulin lispro. The primary objective was non-inferiority in A1C reduction at week 26 versus insulin glargine.
In these clinical trials, Onswik (搜索) demonstrated an overall safety profile similar to the daily basal insulins studied.
Dosing, Device and Safety
Onswik (搜索) is contraindicated in people with type 1 diabetes due to an increased risk of severe hypoglycemia. It is not known whether Onswik is safe and effective in children. Common side effects include low blood sugar, allergic reactions, injection site reactions, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of hands and feet, and weight gain.
Serious side effects that can lead to death include low blood sugar (hypoglycemia), severe whole-body allergic reactions, low potassium in the blood (hypokalemia) and heart failure. Taking thiazolidinediones (TZDs) with Onswik (搜索) may cause heart failure in some people, including those with no history of heart failure or heart problems, and may worsen existing heart failure; healthcare providers should monitor patients closely while TZDs and Onswik are used together.
Patients inject Onswik (搜索) once weekly on the same day of the week, subcutaneously in the stomach area, buttocks, thigh or back of the upper arms. A change in the dosing day is permitted at least four days after the last dose, after which the new weekly schedule continues. A missed dose should be taken as soon as possible within four days (96 hours); if more than four days have passed, the dose should be skipped and the next dose taken on the regularly scheduled day, or the missed dose taken with the weekly schedule restarted one week after that injection. If the one-time starting dose is taken twice in a row, or a weekly dose is taken more than once in the same week, the following week's dose should be skipped. Onswik must not be used in an insulin pump or injected into a vein or muscle, and it must not be diluted or mixed with another insulin or liquid medicine.
The Onswik (搜索) KwikPen is available in two concentrations. The U-500 (500 units/mL) prefilled pen can be injected in 5-unit increments and can deliver up to 400 units in a single injection. The U-1,000 (1,000 units/mL) prefilled pen can be injected in 10-unit increments and can deliver up to 800 units in a single injection. The pens are single-patient-use and must not be shared, even with a needle change. Lilly notes that dosage selection for Onswik differs from other injectable diabetes medicines, and that people who are blind or have vision problems should not use the pen without help from a person trained to use it.
Injection Burden and Disease Context
Onswik (搜索) is designed to reduce injections by more than 300 per year compared with once-daily basal insulin, based on an approximate 52 injections per year for Onswik versus 365 for a once-daily basal insulin. Lilly states that this figure is not intended as a comparison of safety or efficacy.
Around one in eight Americans live with diabetes, and most of them have type 2 diabetes (搜索). Globally, by 2030, more than 510 million people are expected to live with the disease, and 38 million of these are expected to use insulin. Insulin remains an important treatment option for many people with type 2 diabetes who do not achieve glycemic goals with other therapies.
With Onswik (搜索), Lilly's type 2 diabetes (搜索) portfolio expands to include a once-weekly basal insulin alongside existing treatment options across insulins, incretins, oral and injectable medications. The Onswik KwikPen will be available in the U.S. in the coming months in the U-500 and U-1,000 concentrations.