An Eli Lilly insulin engineered for once-weekly dosing now has preliminary results from two more pivotal studies showing the injection was comparable to once-daily insulin, a new slate of data that brings the experimental insulin closer to competing with a Novo Nordisk product that’s already commercially available in some parts of the world.
The Lilly insulin, efsitora alfa, is a fusion protein engineered to provide patients with more stable glucose levels over the course of a week. This experimental insulin is being studied in a broad Phase 3 program spanning five studies — four in type 2 diabetes and one in type 1 diabetes. In total, about 4,000 adult participants are enrolled. The results announced Thursday are from two type 2 diabetes studies; one enrolled participants using basal (long-acting) insulin for the first time and the other enrolled those switching over from daily basal injections.
[Paragraph updated to correct Lantus’s manufacturer.] In the 52-week basal insulin naïve study, Lilly said once-weekly efsitora reduced hemoglobin A1C, a biological indicator of blood sugar levels, by 1.31% compared to 1.27% for insulin glargine, the main ingredient in Sanofi’s once daily insulin product Lantus. This result met the main goal of showing efsitora was statistically non-inferior to once-daily insulin.
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In the separate 78-week study enrolling patients who had previously received basal insulin, efsitora was compared to Tresiba, a once-daily insulin from Novo Nordisk. Lilly said its once-weekly insulin reduced A1C by 0.86% compared to 0.75% in the comparator group, meeting the main goal of showing noninferiority measured at week 26. In both studies, Lilly said its weekly insulin’s safety and tolerability profile was similar to that of daily basal insulins used to treat type 2 diabetes.
“Many patients are reluctant to start insulin because of the burden it places on them,” Jeff Emmick, senior vice president, product development, Lilly, said in a prepared statement. “With a simple fixed-dose regimen, once-weekly efsitora could make it easier for people with diabetes to start and manage insulin therapy, while reducing the impact it has on their day-to-day lives.”
Lilly said detailed results from the two latest Phase 3 studies will be shared at an upcoming congress and submitted for publication in a peer-reviewed journal. These results follow the May announcement of positive preliminary data from two other Phase 3 tests of efsitora in type 2 diabetes. More details from those studies are set for presentation next week during the European Association for the Study of Diabetes annual meeting in Madrid. Lilly has not yet reported data for the fifth Phase 3 test in type 1 diabetes.
Novo Nordisk already has regulatory approvals for its once-weekly insulin, icodec. In Europe, Canada, Australia, Japan, and Switzerland, this product is marketed as Awiqli for the treatment of type 1 and type 2 diabetes. In China, icodec is approved only for type 2 diabetes.
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The FDA rejected Novo Nordisk’s icodec submission in July, asking questions about the manufacturing process and the use of this product in patients with type 1 diabetes. During a May FDA advisory committee meeting, some committee members expressed concern about higher rates of hypoglycemia, or low blood sugar, compared with daily insulin. Novo Nordisk said in July it did not expect to be able to address the regulator’s questions this year.
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