Lilly's Once-Weekly Insulin Efsitora Alfa Shows Promise in Late-Stage Trials

Eli Lilly has unveiled positive results from a suite of late-stage clinical trials for its once-weekly insulin candidate, efsitora alfa, paving the way for global regulatory submissions by year-end. The comprehensive data package, presented at the 85th American Diabetes Association Scientific Sessions in Chicago, demonstrates the potential of efsitora to revolutionize insulin therapy for Type 2 diabetes patients.

Efsitora's Clinical Success Across Multiple Patient Populations

The QWINT program, comprising five trials initiated in 2022, has assessed efsitora's efficacy in over 3,000 Type 2 diabetes patients. The latest results from QWINT-1, QWINT-3, and QWINT-4 studies show that efsitora achieved noninferior A1C reduction compared to daily basal insulin across various patient groups:

• QWINT-1: Insulin-naive patients (n=795)
• QWINT-3: Patients previously using daily basal insulin (n=986)
• QWINT-4: Patients previously using daily basal and mealtime insulin (n=730)

In QWINT-1, efsitora reduced A1C by 1.31% versus 1.27% for insulin glargine at 52 weeks. QWINT-3 and QWINT-4 demonstrated similar efficacy, with A1C reductions of 0.86% and 1.07% respectively at 26 weeks, comparable to daily insulin alternatives.

Safety Profile and Potential Patient Benefits

Efsitora's safety profile was consistent with commonly used daily basal insulins, insulin glargine and insulin degludec. Notably, QWINT-1 reported approximately 40% fewer hypoglycemic events with efsitora compared to insulin glargine.

Jeff Emmick, M.D., Ph.D., Lilly's senior vice president of product development, highlighted the potential impact: "Once-weekly efsitora may offer a significant advancement for people with type 2 diabetes who need insulin by eliminating over 300 injections per year."

The reduced injection frequency could improve treatment adherence and encourage insulin therapy initiation in hesitant patients. Paul Owens, VP of global brand development for insulins and glucagon at Lilly, emphasized this point, stating, "We believe it has the potential to really improve adherence ... and for some, the innovation of a simple, once-weekly approach to dosing could really mean the difference between starting the treatment and not."

Regulatory Outlook and Market Implications

Lilly plans to submit its efsitora package to global regulators by the end of 2025. This move positions the company to potentially take the lead in the U.S. market for once-weekly insulins, as rival Novo Nordisk faces regulatory hurdles with its own candidate, insulin icodec (Awiqli).

While Awiqli has gained approvals in Europe, Canada, Japan, and Australia, it received an FDA rejection in July, primarily due to manufacturing process concerns and questions surrounding its use in Type 1 diabetes. This setback has opened a window of opportunity for Lilly in the U.S. market.

As the pharmaceutical industry continues to innovate in diabetes care, efsitora's progress represents a significant step towards simplifying insulin therapy and potentially improving outcomes for millions of patients with Type 2 diabetes.