Eli Lilly is advancing its development of a once-weekly insulin, efsitora alfa, designed for people with diabetes, bringing it a step closer to competing with similar products like Novo Nordisk’s already available insulin icodec. As part of a comprehensive Phase 3 program which includes five studies — four focusing on type 2 diabetes and one on type 1 diabetes — preliminary results were announced from two pivotal studies examining efsitora in type 2 diabetes patients. These findings are significant as they involve about 4,000 adult participants and highlight the potential of efsitora to simplify diabetes management.
The first of these studies, which lasted 52 weeks, examined participants who were new to using basal insulin. In this study, efsitora showed a reduction in hemoglobin A1C by 1.31%, a key indicator of blood sugar levels, compared to a 1.27% reduction seen with insulin glargine, the active ingredient in Sanofi’s daily insulin product Lantus. These outcomes demonstrated that once-weekly efsitora was statistically non-inferior to the daily regimen, achieving its main study goal.
The second study, spanning 78 weeks, involved participants previously treated with basal insulin and compared the effects of efsitora to Tresiba, another daily insulin from Novo Nordisk. Results showed that efsitora achieved a reduction in A1C by 0.86% over the comparator’s 0.75% at the 26-week point, again confirming non-inferiority to the once-daily insulin. Both studies reported that efsitora’s safety and tolerability profile was comparable to those of the daily basal insulin treatments typically used in type 2 diabetes.
Jeff Emmick, senior vice president of product development at Lilly, emphasized the potential benefits of once-weekly efsitora, noting that it could ease the initiation and management of insulin therapy for people with diabetes by reducing the daily burden associated with such treatments.
Detailed results from these studies are planned to be presented at future scientific congresses and published in peer-reviewed journals. This follows previous announcements in May regarding positive preliminary data from two other Phase 3 studies of efsitora, with more detailed information expected to be disclosed at the upcoming annual meeting of the European Association for the Study of Diabetes in Madrid.
In contrast to Lilly’s ongoing efforts and promising results, Novo Nordisk’s once-weekly insulin, icodec, has already secured regulatory approval in various global markets including Europe, Canada, Australia, Japan, and Switzerland, where it’s marketed as Awiqli for both type 1 and type 2 diabetes. In China, the approval is limited to type 2 diabetes.
However, icodec has faced challenges in the United States. The FDA rejected Novo Nordisk’s submission for icodec in July, citing concerns over manufacturing processes and its application in type 1 diabetes patients. The rejection was partly influenced by observations of higher hypoglycemia rates compared to daily insulin during an advisory committee meeting in May. Novo Nordisk has indicated delays in addressing these regulatory concerns within the current year.
These developments reflect ongoing advancements and competition in the field of diabetes treatment, particularly in the development of more convenient insulin dosing options that aim to improve quality of life for patients managing this chronic condition. As the market for diabetes care evolves, these innovations represent crucial steps toward more flexible and less burdensome therapeutic regimens.
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