Eli Lilly LLY announced positive topline results from two phase III studies, QWINT-1 and QWINT-3, which evaluated efsitora alfa, its once-weekly administered investigational insulin, in adults with type II diabetes (T2D).
LLY’s Weekly Insulin Shot Matches Daily Insulin
The QWINT-1 study compared efsitora to daily injections of Sanofi’s SNY Lantus (insulin glargine) for 52 weeks in T2D patients using basal insulin for the first time. The QWINT-3 study compared efsitora with daily shots of Novo Nordisk’s NVO Tresiba (insulin degludec) for 78 weeks in T2D patients who have switched from daily basal insulin injections. The NVO and SNY injections are the most frequently-used daily basal insulins in the world.
Both studies met their primary endpoint. Study participants who received efsitora achieved a non-inferior reduction of A1C (a measure of average blood sugar) that was similar to daily shots of Lantus and Tresiba. The safety and tolerability profile of efsitora was in line with those of the daily basal insulin therapies.
These above results are also consistent with positive results on the late-stage QWINT-2 and QWINT-4 studies that were reported by Lilly in May. While the QWINT-2 study compared efsitora with Novo’s Tresiba in T2D patients using basal insulin for the first time, the QWINT-4 study evaluated efsitora against Sanofi’s Lantus in T2D patients who require multiple insulin shots on a daily basis. These studies achieved their primary endpoint of non-inferior reduction of A1C.
All the above four late-stage studies are part of the QWINT phase 3 global clinical development program on efsitora in diabetes patients. The company intends to report data from the QWINT-5 study later this year. The last study in this program, QWINT-5, compares efsitora to Tresiba in type I diabetes (T1D) patients treated with multiple daily injection therapy.
Year to date, Eli Lilly’s shares have surged 56.6% compared with the industry’s 27.0% rise.
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How the Results Benefit Lilly?
Most insulins approved in the United States require taking injections at least once a day. A once-in-a-week administered insulin will help ease the burden for many patients, who are reluctant to start insulin therapy.
Results from the above studies will likely help Lilly when it decides to seek regulatory approval for efsitora in diabetes patients. Currently, there are no approved insulins in the United States that require weekly administrations.
The results allow Lilly to catch up to Novo, which already markets a once-weekly insulin called Awiqli in Europe, Canada, Australia, Japan and China. NVO faced a major setback in July when the FDA rejected approving the company’s filing seeking approval for this weekly insulin.
Per the complete response letter issued to Novo, the FDA requested information related to the manufacturing process and the T1D indication before it could complete the review of the application. Novo does not expect to be able to respond to the FDA’s queries before next year.
The setback to Novo acts as a boon for Lilly. The FDA rejection postpones Novo’s weekly insulin launch in the country, reducing the time difference between its potential release and Lilly's efsitora.
Eli Lilly and Company Price
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Zacks Rank
Eli Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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