A Zepbound injection pen, Eli Lilly’s weight loss drug, is seen in New York, U.S., December 11, 2023.
Brendan McDermid | Reuters
Eli Lilly on Wednesday said the wildly popular weight-loss drug Zepbound has shown potential in treating patients with the most common sleep-related breathing disorder in two late-stage clinical trials.
The initial results add to the long list of potential health benefits of the weight-loss and diabetes treatments, which have exploded in demand in the past year despite their high prices and poor insurance coverage.
Zepbound was more effective than a placebo in reducing severity obstructive sleep apnea, or OSA, in obese patients after one year, according to preliminary data from both trials. OSA refers to the cessation of breathing during sleep due to narrowed or blocked airways. The pharmaceutical giant said it plans to present the results at an upcoming medical conference and submit them to the Food and Drug Administration and regulators in other countries by mid-2024.
Eli Lilly previously announced that the FDA has cleared Zepbound “fast path name” for patients with moderate to severe OSA and obesity. This designation ensures that drugs intended to treat a serious or life-threatening condition and fill an unmet medical need will be reviewed more quickly.
Shares of Eli Lilly rose 2% early Wednesday.
The results are an early sign of hope for the estimated 80 million patients in the US who experience OSA, Eli Lilly said in a news release. About 20 million of these people have moderate to severe forms of the disease, but 85% of OSA cases go undiagnosed, according to Eli Lilly.
OSA can lead to excessive daytime sleepiness; and loud snoring, as well as contributing to serious complications such as hypertension, stroke and heart failure. Patients with the condition have limited treatment options other than the burdensome and often uncomfortable machines which provide positive airway pressure, or PAP, to allow normal breathing.
“Addressing this unmet need is critical, and while there are drug treatments for excessive sleepiness associated with OSA, [Zepbound] has the potential to be the first drug treatment for the underlying disease,” said Dr. Jeff Emmick, Eli Lilly’s senior vice president of product development, in the announcement Wednesday.
Zepbound has slipped into shortages since receiving US approval for weight management in November. Zepbound’s active ingredient, known as tirzepatide, is also approved under the brand name Mounjaro for diabetes.
Mounjaro and other diabetes medications are usually covered by insurance, while Zepbound and other weight loss medications are not. But the new data in sleep apnea patients gives Eli Lilly a “pathway to obtain Medicare Part D coverage for Zepbound,” even before any changes to the federal program’s coverage of obesity treatments, he wrote in a note Wednesday JPMorgan Chase analyst Chris Schott.
Under new guidance issued in late March, Medicare may cover certain weight-loss drugs if they are approved by the FDA for an added health benefit. Medicare prescription drug plans run by private insurance companies, known as Part D, currently cannot cover these weight loss-only drugs.
Schott added that the new data gives Eli Lilly a path to increase the use of Zepbound in men. He said the company has suggested that men may be more likely to use a so-called GLP-1 drug like Zepbound for sleep apnea compared to obesity.
Eli Lilly’s Zepbound works by mimicking two naturally produced gut 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.
Initial test results
The two phase three trials, both called SURMOUNT-OSA, tested Zepbound in two groups of patients. Notably, 70% of participants in all studies were male, Eli Lilly said in its release.
The researchers looked specifically at how much the weekly injection reduced the so-called apnea-hypopnea index, or AHI, which records how many breaths per hour a person exhibits a restricted or completely blocked airway. The score is used to assess the severity of obstructive sleep apnea and the effectiveness of treatments for the condition.
In both individual studies, Zepbound was superior to placebo in reducing AHI, which was the main objective of the trials.
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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 over 52 weeks, compared with an average reduction of 4.8 events per hour for the placebo, the results showed.
Zepbound also met the trial’s second objective, leading to an overall reduction in AHI of 55% compared with a 5% reduction for placebo, the results say.
The second study tested Zepbound in adults with the same conditions, but these patients were on and planned to continue PAP treatment.
People taking Zepbound had an average of 30.4 fewer AHI events per hour at 52 weeks, compared with an average reduction of 6 events per hour for placebo.
Zepbound led to an overall reduction in AHI of almost 63%, compared to a reduction of more than 6% for placebo.
The results beat Wall Street expectations. Investors largely viewed a 50% reduction as the threshold to consider Eli Lilly’s trials successful. The roughly 60% improvement points to “big gains,” Deutsche Bank analyst James Shin wrote in a note on Wednesday.
In both 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 treatments like Zepbound.
In a note Wednesday, Morgan Stanley analyst Terence Flynn called that weight reduction encouraging and said the company expects a 15% to 18% weight loss in the test. Morgan Stanley sees “this as another positive data point supporting the efficacy profile of tirzepatide,” Flynn said.