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.
Lilly’s VP of global brand development for insulins/glucagon Paul Owens 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 denial 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 only for type 2 diabetes.