Results from two clinical trials showed that a once-weekly version of insulin developed by Eli Lilly was as successful at regulating blood sugar in people with diabetes as the routinely used daily injections. Lilly is betting that its experimental medication, insulin efsitora alfa, may offer a more convenient and long-lasting alternative to daily diabetic therapy.
According to a statement released by Lilly’s senior vice president of product development, Jeff Emmick, “With efsitora, we have an opportunity to provide an innovative once-weekly solution that safely achieves and maintains A1C control, reduces the treatment burden of traditional daily injections, and potentially improves adherence for people with diabetes.”
Lilly is one of the leading producers of diabetic medications, along with competitor Novo Nordisk. Lilly offers a variety of drugs, including several insulins. The companies’ so-called GLP-1 medications, which increase the body’s release of insulin to treat diabetes, have garnered increased attention recently. These medications have also been shown to be quite successful in helping people lose weight.
Even while both medications became overnight successes, boosting Lilly and Novo’s market values by hundreds of billions of dollars, both companies are still devoting resources to creating novel insulin therapies. Lilly’s response to Novo’s insulin icodec, likewise given as a weekly injection and recently suggested for approval in Europe, is called efsitora. FDA advisors will convene to deliberate on Novo’s application for approval in the United States.
Two of the five Phase 3 efsitora studies that Lilly is conducting had findings released. The first, known as QWINT-2, evaluated efsitora against once-daily insulin degludec in patients with Type 2 diabetes who were insulin-naive for a year. A1C readings, a gauge of blood sugar, were 1.34% lower at week 52 after starting efsitora medication than they were 1.26% lower after starting insulin degludec. The A1C readings in both groups were below the standard target threshold of 7% for therapy.
In the second study, known as QWINT-4, efsitora was examined in a more severely ill group of diabetics who had previously had treatment with basal insulin and at least two daily injections of insulin for meals. Both efsitora and insulin glargine, the daily comparator, decreased A1C levels by 1.07% after 26 weeks.
Except for severe or clinically significant hypoglycemia episodes, Lilly defined efsitora as “safe and well-tolerated” in both tests. However, no specific side effects were included in the press statement on Thursday. Researchers found that patients receiving efsitora experienced 0.58 hypoglycemia episodes per patient-year of exposure in QWINT-2, whereas those receiving insulin degludec experienced 0.45. In QWINT-4, the corresponding rates for efsitora and insulin glargine were 5.9 and 6.6.
Lilly, Novo, and former competitor Sanofi have come under scrutiny for the prices of insulin medicines currently on the market. All three of them cut the list prices of their insulins last year in response to persistent political pressure. The action was taken in tandem with recent legislative modifications that removed a ceiling on rebates paid into Medicaid and capped Medicare beneficiaries’ out-of-pocket insulin expenses at $35 per month. The net pricing of the medications was far less than their list prices because the companies had been giving insurers sizable rebates for their insulin supplies.
