- Lilly's once-weekly insulin, efsitora alfa, demonstrates effective A1C reduction in Phase 3 trials.
- Efsitora achieves comparable safety profile to daily insulins, reducing annual injections by over 300.
- Lilly plans regulatory submission of efsitora by end of 2025, potentially simplifying diabetes management.
Eli Lilly and Company (LLY, Financial) announced encouraging results from three Phase 3 clinical trials for its once-weekly insulin, efsitora alfa, designed for type 2 diabetes management. The trials, QWINT-1, QWINT-3, and QWINT-4, demonstrated that efsitora met the primary endpoints by achieving non-inferior A1C reduction compared to daily basal insulin regimens.
In the QWINT-1 trial, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine over 52 weeks, showing 40% fewer hypoglycemic events. QWINT-3 results revealed a 0.86% A1C reduction versus 0.75% for insulin degludec over 26 weeks, while QWINT-4 exhibited a 1.07% reduction matching insulin glargine. These findings indicate that efsitora's once-weekly dosing could replace over 300 annual injections, significantly relieving treatment burden and enhancing patient compliance.
Efsitora's safety profile remained consistent with existing insulin options, showing comparable rates of hypoglycemia across trials. The innovative fixed-dose regimen tested in QWINT-1 provides an easier therapeutic approach with only four titration steps, potentially making insulin therapy more accessible for patients with type 2 diabetes.
Lilly plans to submit efsitora for regulatory approval by the end of 2025, aiming to introduce a revolutionary option to the diabetes care market, improving patient adherence and quality of life while maintaining effective glycemic control.
