FDA Clears Once-Weekly Insulin Efsitora for Adults With Type 2 Diabetes
The FDA approved efsitora (Onswik), a once-weekly basal insulin, for adults with type 2 diabetes as an addition to diet and exercise. It is not indicated for children or people with type 1 diabetes because of severe hypoglycemia risk. Phase III QWINT trials showed non-inferior HbA1c reductions compared with daily basal insulins, with a similar safety profile.
Efsitora (Onswik) is a weekly basal insulin approved for adults with type 2 diabetes to use alongside diet and exercise. It is not cleared for children or people with type 1 diabetes because of severe hypoglycemia concerns. The QWINT phase III program enrolled more than 3,400 people across four international trials. Across those studies, it matched daily basal insulins for HbA1c reduction and showed a comparable safety profile.
It becomes the second weekly basal insulin for type 2 diabetes, following insulin icodec (Awiqli), approved in March. Eli Lilly intends to release the Onswik KwikPen in two strengths: 500 units/mL and 1,000 units/mL.
Adults with type 2 diabetes who need basal insulin could benefit from fewer injections, which may improve convenience and adherence. Clinicians may gain another weekly option, though hypoglycemia monitoring remains important. The arrival of a second weekly insulin could increase competition, potentially influencing access or pricing over time. Children and people with type 1 diabetes are not candidates, so the impact would likely remain concentrated among adults with type 2 diabetes.