An injection pen containing Eli Lilly's weight-loss drug Zepbound is on display in New York City, U.S., December 11, 2023.
Brendan McDermid | Reuters
Eli Lilly said Wednesday that its highly popular weight-loss drug Zepbound showed the potential to treat patients with the most common sleep-related breathing disorder in two late-stage clinical trials.
The early results add to the long list of potential health benefits of weight loss and diabetes treatments, demand for which has soared in the past year despite high prices and poor insurance coverage.
According to preliminary data from both studies, Zepbound was more effective than a placebo at reducing the severity of obstructive sleep apnea (OSA) in obese patients after one year. The pharmaceutical giant said it plans to present the results at an upcoming medical conference and submit them to the U.S. Food and Drug Administration and regulators in other countries by the middle of this year.
Eli Lilly previously announced that the FDA has granted Zepbound a “fast track designation” for patients with moderate to severe OSA and obesity. This designation accelerates the assessment of medicines that treat a serious or life-threatening condition and meet an unmet medical need.
Shares of Eli Lilly rose 2% in early trading on Wednesday.
The results are an early sign of hope for the estimated 80 million patients in the US who suffer from OSA, which refers to interrupted breathing during sleep due to narrowed or blocked airways. About 20 million of these people have moderate to severe forms of the disease, but according to Eli Lilly, 85% of OSA cases go undiagnosed.
OSA can lead to excessive daytime sleepiness, loud snoring, and can contribute to serious complications, including high blood pressure, stroke, and heart failure. Patients with the condition have limited treatment options, aside from cumbersome and often uncomfortable machines that provide positive airway pressure (PAP) to allow normal breathing.
“It is critical to address this unmet need head-on, and while pharmaceutical treatments exist for the excessive sleepiness associated with OSA, [Zepbound] has the potential to be the first pharmaceutical treatment for the underlying disease,” said Dr. Jeff Emmick, Eli Lilly's senior vice president of product development, said in a news release Wednesday.
Zepbound has been in shortages since gaining approval for weight management in the US in November. The active ingredient in Zepbound, known as tirzepatide, is also approved under the brand name Mounjaro for diabetes.
Mounjaro and other diabetes medications are typically covered by insurance, while Zepbound and other weight loss medications are not. But the new data on sleep apnea patients gives Eli Lilly a “pathway to obtaining Medicare Part D coverage for Zepbound” even before there was any change to the federal program's coverage of obesity treatments, JPMorgan Chase analyst Chris Schott wrote Wednesday in a note.
Under new guidance last month, Medicare can cover certain weight loss medications as long as they receive FDA approval for an additional health benefit. Medicare prescription drug plans administered by private insurers, known as Part D, currently cannot cover these medications for weight loss alone.
Schott added that the new data provides Eli Lilly with a way to increase Zepbound use among men. He said the company has suggested that men are more likely to use a so-called GLP-1 drug like Zepbound for sleep apnea compared to obesity.
Eli Lilly's Zepbound works by imitating two naturally produced intestinal hormones called GLP-1 and GIP. GLP helps reduce food intake and appetite. GIP, which also suppresses appetite, can also improve the way the body breaks down sugar and fat.
First test results
The two phase three trials, both called SURMOUNT-OSA, tested Zepbound in two groups of patients. It was striking that 70% of the participants in the studies were men.
Researchers specifically examined how much the weekly injection reduced the so-called apnea-hypopnea index, or AHI, which records the number of times per hour a person's breathing shows a restricted or completely blocked airway. The index is used to evaluate the severity of obstructive sleep apnea and the effectiveness of treatments for the condition.
In both sub-studies, Zepbound was superior to placebo in reducing AHI, which was the main goal of the studies.
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The first study evaluated the drug in adults with moderate to severe obstructive sleep apnea and obesity who were not receiving PAP therapy.
People taking Zepbound had an average of 27.4 fewer AHI events per hour after 52 weeks, compared to an average reduction of 4.8 events per hour for the placebo.
Zepbound also met the second aim of the study, leading to an overall AHI reduction of 55% compared to a 5% reduction for the placebo.
In the second study, Zepbound was tested in adults with the same conditions, but these patients were on PAP therapy and planned to continue it.
People taking Zepbound had an average of 30.4 fewer AHI events per hour after 52 weeks, compared to an average reduction of 6 events per hour for the placebo.
Zepbound led to an overall AHI reduction of almost 63% compared to a reduction of more than 6% for the placebo.
The results exceeded Wall Street expectations. Investors largely viewed a 50% cut as the threshold for considering Eli Lilly's trials a success. The roughly 60% improvement shows “outsized upside,” Deutsche Bank analyst James Shin wrote in a note on Wednesday.
In the two studies, Zepbound helped patients lose about 20% of their weight. But Eli Lilly noted that men are known to achieve less weight loss than women with therapies such as Zepbound.
In a note on Wednesday, Morgan Stanley analyst Terence Flynn called that weight reduction encouraging, saying the company expected a 15% to 18% weight loss during the trial. Morgan Stanley views “this as another positive data point supporting the efficacy profile of tirzepatide,” Flynn said.
Specifically, Eli Lilly's main rival Novo Nordisk does not investigate proprietary medications for weight loss and diabetes in patients with sleep apnea.