FDA Approves Efsitora Weekly Insulin for Type 2 Diabetes

The FDA approved the once-weekly basal insulin efsitora (Onswik), drugmaker Eli Lilly announced on Thursday.

Indicated as an adjunct to diet and exercise for adults with type 2 diabetes, the therapy delivers steady basal insulin levels over 7 days. It is not approved for pediatric patients or individuals with type 1 diabetes due to a higher risk of severe hypoglycemia.

“Onswik is designed to reduce injections by over 300 per year versus once-daily basal insulin,” Lilly noted in a statement. “Insulin remains an important treatment option for many people with type 2 diabetes who do not achieve glycemic goals with other therapies.”

Pivotal trial lead investigator Julio Rosenstock, MD, of Velocity Clinical Research at Medical City in Dallas, previously called efsitora “a new and further step in that direction to make life much easier for people with type 2 diabetes who need insulin.”

Underpinning the approval were data from QWINT phase III clinical trials, which enrolled over 3,400 participants across four global studies.

In QWINT-1, which enrolled insulin-naïve adults with type 2 diabetes, insulin efsitora demonstrated non-inferiority at reducing HbA1c by week 52 compared with once-daily insulin glargine U-100.

QWINT-2 also enrolled insulin-naïve adults with type 2 diabetes and showed non-inferiority in reducing HbA1c compared with insulin degludec U-100. Additionally, this trial demonstrated safety and efficacy among patients using and not using GLP-1 receptor agonists.

In QWINT-3, which evaluated patients switching from daily basal insulin, efsitora achieved non-inferior HbA1c reductions at 26 weeks compared with insulin degludec U-100.

QWINT-4 enrolled patients on more complex regimens involving basal insulin and at least two injections per day of mealtime insulin. Here, efsitora showed non-inferior HbA1c reductions compared with once-daily insulin glargine U-100 at week 26. Efsitora and glargine were both administered subcutaneously along with insulin lispro.

“In these clinical trials, Onswik demonstrated an overall safety profile similar to the daily basal insulins studied,” the drugmaker noted.

The most common adverse reactions include hypoglycemia, hypersensitivity reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain. The label warns against use during active hypoglycemic episodes.

Prescribing information also cautions against medication errors, hypokalemia, and potential fluid retention or heart failure when co-administered with PPAR-gamma agonists, such as thiazolidinediones.

Insulin efsitora is now the second once-weekly basal insulin for type 2 diabetes, joining insulin icodec (Awiqli), which was approved in March.

Eli Lilly plans to launch the Onswik KwikPen in the coming months in two concentration formats: 500 units/mL (1,500 total units per pen) and 1,000 units/mL (3,000 total units per pen).