The FDA approves Eli Lilly's weight-loss drug Zepbound for sleep apnea
An Eli Lilly & Co. Zepbound injection pen was arranged on Thursday, March 28, 2024, in the New York City borough of Brooklyn, USA.
Shelby Knowles | Bloomberg | Getty Images
The Food and Drug Administration gave approval Friday Eli LillyZepbound, the blockbuster weight-loss drug developed to treat patients with the most common sleep-disordered breathing disorder, is expanding its use and potentially insurance coverage in the United States
The weekly injection is now the first drug treatment option approved for patients with obesity and moderate to severe obstructive sleep apnea (OSA). These are pauses in breathing during sleep due to narrowed or blocked airways. Zepbound should be used in combination with a reduced-calorie diet and increased physical activity, the FDA noted in a news release.
According to Eli Lilly, an estimated 80 million patients in the United States suffer from this disease. About 20 million of those people suffer from moderate to severe forms of the disease, but 85% of cases go undiagnosed, the company told CNBC earlier this year.
“Too often, OSA is dismissed as 'just snoring' – but it is much more than that,” said Julie Flygare, president and CEO of Project Sleep, a nonprofit organization that advocates for sleep health and sleep disorders, in an Eli Lilly press release . “It is important to understand OSA symptoms and know that treatments are available, including new options like Zepbound. We hope this will lead to more meaningful conversations between patients and healthcare providers and ultimately lead to better health outcomes.”
Eli Lilly expects to bring the OSA drug to market early next year. It is the first approval beyond the treatment of obesity for Zepbound, which came to market late last year and is also being tested for several other obesity-related diseases such as fatty liver disease. Tirzepatide, the active ingredient in Zepbound, has long been sold on the US market as the diabetes drug Mounjaro.
The agency's decision could pave the way for Eli Lilly to get more comprehensive insurance coverage for Zepbound, which like other weight-loss drugs isn't covered by many insurance plans. This includes the federal Medicare program, which only covers obesity medications if they are approved and prescribed for additional health benefits.
The approval also underscores growing evidence that GLP-1 may bring additional health benefits, a class of weight loss and diabetes treatments that have surged in popularity and been in short supply over the past year. In particular, Zepbound's main competitor, the weight loss drug Wegovy Novo Nordiskis not approved for OSA.
Zepbound could be a valuable new treatment option for patients with OSA, which can cause loud snoring and excessive daytime sleepiness and lead to serious complications such as stroke and heart failure. Patients with this condition have limited treatment options beyond wearing masks attached to cumbersome machines that generate positive airway pressure (PAP) to allow normal breathing.
Eli Lilly released initial results from two clinical trials in April that showed Zepbound was more effective than a placebo in reducing the severity of OSA in patients with obesity after one year.
In June, Eli Lilly released additional data from the trials showing that Zepbound helped
resolve OSA in almost half of patients. The first study examined weekly injections in adults with moderate to severe OSA and obesity who were not receiving PAP therapy. The second study tested Zepbound in adults with the same conditions, but these participants were on PAP therapy and planned to continue it.
The data showed that 43% of people in the first study and 51.5% of patients in the second study who took the highest dose of Zepbound achieved “disease resolution,” according to the company. This compares to 14.9% and 13.6% of patients who took a placebo in the two studies, respectively.
Researchers came to these conclusions by studying an apnea-hypopnea index (AHI), which records how many 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 treating the condition.
The company explained that disease resolution in OSA is defined as a patient experiencing fewer than five AHI events per hour. According to Eli Lilly, it is also defined as a person who has five to 14 AHI events per hour and scores a certain number on a standard survey measuring excessive daytime sleepiness.
