FDA Approves Onswik: A Once-Weekly Insulin For Adults With Type 2 Diabetes

If you live with type 2 diabetes (T2D) and find the frequency of multiple daily injections (MDI) daunting, here’s a bit of good news: Eli Lilly announced the Food and Drug Administration (FDA) approval of its once-weekly basal insulin, Onswik, for use in adults living with T2D.

Unlike other basal insulins, which have to be administered once or even twice daily, this once-a-week option reduces both the physical and mental challenges of the disease—making it a gamechanger when it comes to managing T2D on a daily basis.

The latest FDA approval joins other regulatory approvals from the European Medicines Agency (EMA), Mexico’s Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

What does this mean for people living with T2D?

People with diabetes make up to 180 extra health-related decisions on a daily basis. With this approval, it’s one fewer daily decision when managing their blood glucose levels. 

Taking basal insulin only once a week instead of once or twice a day, while maintaining similar glycemic control, alleviates a major burden for people living with T2D.

“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,” said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health. “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.” 

This approval adds another once-a-week treatment option, in addition to Awiqli from Novo, for people who have shied away from the burden of MDI. Once-weekly insulins reduce injection burden by 85% and are proven to improve adherence to insulin treatment.

The FDA approval is supported by data from Lilly’s QWINT Phase 3 clinical trial, which showed that Onswik had a comparable efficacy level to once-daily insulin products like insulin glargine U-100 and insulin degludec U-100. In the trial, Onswik lowered A1C by 1.34%, compared with a 1.26% reduction in participants who took degludec.

What you should know before before starting Onswik

Onswik works differently from daily basal insulin, so there are a few things to go over with your healthcare provider before you switch. Here are a few things to keep in mind:

• Onswik won’t replace the need for bolus (short-acting) insulin taken for meals. 
• Onswik should not be used in an insulin pump. 
• Common side effects include low blood sugar, injection-site reactions, weight gain and swelling of hands and feet.
• Onswik hasn’t been approved for use in type 1 diabetes because of the risk of severe hypoglycemia.

When will Onswik be available?

People with insulin-dependent type 2 diabetes need and deserve more treatment options for care. This FDA approval is a step in the right direction and provides more flexibility and freedom to people living with T2D who need insulin. 

Onswik will be available via KwikPen in the United States in the coming months. It will be available in two concentrations: 500 units/mL (contains 1,500 units per pen) and 1,000 units/mL (contains 3,000 units per pen). Talk to your healthcare provider if you live with T2D, are insulin-dependent and are interested in trying Onswik instead of a daily basal insulin.

Want to learn more about managing T2D? Check out the Beyond Diagnosis Guide.