Lilly’s Once-Weekly Insulin Efsitora Alfa Achieves Non-Inferiority in Four Phase 3 Trials
Efficacy:
Eli Lilly's once-weekly insulin efsitora alfa has demonstrated non-inferiority to daily basal insulin in four Phase 3 trials (QWINT-1, QWINT-2, QWINT-3, and QWINT-4) for controlling blood sugar levels in adults with Type 2 diabetes.
A1C Reduction:
In QWINT-1, efsitora alfa reduced A1C levels by 1.31% compared to 1.27% for insulin glargine at week 52. In QWINT-3, efsitora alfa lowered A1C by 0.86%, versus 0.75% for insulin degludec at 26 weeks.
Safety and Tolerability:
Efsitora alfa was found to be safe and well-tolerated, with similar side effect profiles to daily basal insulin therapies. Severe or clinically significant hypoglycemic events occurred at comparable rates between efsitora alfa and insulin degludec.
Market Competition:
Lilly's efsitora alfa is in direct competition with Novo Nordisk's once-weekly basal insulin icodec, which recently received a positive recommendation for approval in Europe but faced FDA approval issues in the U.S..
Clinical Significance:
Once-weekly insulins like efsitora alfa have the potential to transform diabetes care by reducing the treatment burden and improving adherence for people with diabetes.