On Thursday, Eli Lilly dropped more data for its once-weekly insulin candidate in adults with type 2 diabetes.
In two Phase 3 trials, dubbed QWINT-1 and QWINT-3, Lilly’s efsitora alfa showed non-inferior A1C reduction compared with the most frequently used daily basal insulins, with both studies hitting primary endpoints, Lilly said.
In QWINT-1, efsitora was compared to the daily insulin glargine for 52 weeks in insulin naïve patients with type 2 diabetes. The study hit the primary endpoint of non-inferior A1C reduction, with efsitora reducing A1C by 1.31% compared to 1.27%.
Meanwhile, in QWINT-3, Lilly’s once-weekly insulin was compared to insulin degludec in patients with type 2 diabetes who are taking basal insulin. That trial also hit the primary endpoint, with efsitora reducing A1C by 0.86% compared to 0.75%. Lilly also said that patients on its insulin spent 62.8% of the time within their target glucose range compared to 61.3% for insulin degludec.
Paul OwensLilly and Novo Nordisk are racing to get a once-weekly insulin to many markets. Novo hit a roadblock last month when the FDA turned down its weekly insulin despite approvals in Europe and other regions.
Paul Owens, Lilly’s VP of global brand development for insulins/glucagon, told Endpoints News that “weekly insulin is an area of significant interest to Lilly and we will continue to make data-driven decisions on future development and regulatory submissions.”
As for safety, in QWINT-1, Lilly estimated that combined rates of severe or clinically significant hypoglycemic events were 0.50 with efsitora versus 0.88 with insulin glargine, showing a 40% lower rate of hypoglycemic events with its candidate compared to insulin glargine.
More data are still to come for both QWINT-1 and QWINT-3, to be shared at an upcoming conference. Lilly previously touted data from two other Phase 3 trials for the candidate — QWINT-2 and QWINT-4 — in May, both of which hit all endpoints.
Novo Nordisk’s longer-acting insulin, marketed as Awiqli, was rejected by the FDA in July. The agency requested more information relating to the manufacturing process and the type 1 diabetes indication, and Novo said at the time that it likely wouldn’t refile for approval until 2025.
The no-go from the FDA comes after the drug faced an advisory committee over concerns about increased rates of hypoglycemia among type 1 diabetes patients who took the once-weekly treatment compared to those who took daily insulin. The committee voted 7-4 that the benefits did not outweigh the risks of low blood sugar in patients with type 1 diabetes.
The EU, Canada, Australia, Japan and Switzerland already approved Awiqli (insulin icodec) for both type 1 and type 2 diabetes, while in China it’s only approved for type 2 diabetes.