Lilly reveals promising late-stage data for weekly insulin

Eli Lilly has shared promising new data for its once-weekly insulin candidate, efsitora alfa, in adults with type 2 diabetes. The data come from two Phase 3 trials, QWINT-1 and QWINT-3, both of which met their primary endpoints by demonstrating non-inferior A1C reduction compared to daily basal insulins.

In the QWINT-1 trial, which included insulin-naïve patients with type 2 diabetes, efsitora was compared to daily insulin glargine over a 52-week period. The results showed that efsitora achieved a 1.31% reduction in A1C levels, while insulin glargine resulted in a 1.27% reduction. This confirmed that efsitora is at least as effective as the daily insulin option for managing blood glucose levels.

The QWINT-3 trial compared efsitora to insulin degludec in patients with type 2 diabetes who were already using basal insulin. In this study, efsitora reduced A1C levels by 0.86%, compared to a 0.75% reduction achieved by insulin degludec. Additionally, patients on efsitora spent 62.8% of their time within the target glucose range, slightly higher than the 61.3% for those on insulin degludec.

These findings are significant as Eli Lilly and Novo Nordisk are in a competitive race to introduce a once-weekly insulin to various markets. Novo Nordisk recently encountered a setback when the FDA declined to approve its weekly insulin, Awiqli, even though it has received approvals in Europe and other regions.

Paul Owens, Vice President of global brand development for insulins/glucagon at Lilly, emphasized the company's commitment to advancing weekly insulin options. He noted that Lilly will continue to make decisions based on data for future development and regulatory submissions.

Regarding safety, the QWINT-1 study indicated that efsitora had a lower rate of severe or clinically significant hypoglycemic events compared to insulin glargine. Specifically, the rate was 0.50 for efsitora versus 0.88 for insulin glargine, marking a 40% reduction in such events for those using efsitora.

Further data from both QWINT-1 and QWINT-3 trials are expected to be presented at an upcoming conference. Earlier in May, Lilly had also shared favorable outcomes from two other Phase 3 trials, QWINT-2 and QWINT-4, which met all their endpoints.

On the other hand, Novo Nordisk's once-weekly insulin, Awiqli, faced a rejection from the FDA in July. The rejection cited the need for more information on the manufacturing process and its use for type 1 diabetes. Novo Nordisk indicated that it might not reapply for FDA approval until 2025.

The FDA's decision followed concerns from an advisory committee regarding increased rates of hypoglycemia among type 1 diabetes patients using Awiqli compared to those on daily insulin. The committee voted 7-4 that the benefits did not outweigh the risks of low blood sugar for type 1 diabetes patients.

Despite this, Awiqli (insulin icodec) has garnered approval in the EU, Canada, Australia, Japan, and Switzerland for both type 1 and type 2 diabetes, while in China it’s approved solely for type 2 diabetes.