Eli Lilly & Co. injection pen. Zepbound takes place in Brooklyn, New York, United States, on Thursday, March 28, 2024.
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The Food and Drug Administration approved it on Friday Eli LillyBlockbuster weight loss drug Zepbound to treat patients with the most common sleep-related breathing disorders, expanding its use and possibly insurance coverage in the United States.
The weekly injection is now the first drug treatment option available for patients with obesity and moderate to severe obstructive sleep apnea, or OSA, which refers to sleep apnea due to narrowing or blockage of the airways. The US Food and Drug Administration noted in a statement that Zepbound should be used in combination with a low-calorie diet and increased physical activity.
An estimated 80 million patients in the United States suffer from this disease, according to Eli Lilly. Nearly 20 million of those people have moderate to severe forms of the disease, but 85% of cases go undiagnosed, the company told CNBC earlier this year.
“Too often, sleep apnea is dismissed as just snoring — but it's more than that,” Julie Flygar, president and CEO of Project Sleep, a nonprofit that advocates for sleep health and sleep disorders, said in a statement from Eli Lilly. Much.” “It is important to understand the symptoms of obstructive sleep apnea (OSA) 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 launch OSA early next year. This is the first post-obesity approval for Zepbound, which entered the market late last year and is also being tested for several other obesity-related conditions, such as fatty liver disease. Tirzepatide, the active ingredient in Zepbound, has been sold on the US market for a longer time as the diabetes drug Mounjaro.
The agency's decision could pave the way for Eli Lilly to obtain broader insurance coverage for Zepbound, which, like other weight loss drugs, is not covered by many insurance plans. This includes the federal Medicare program, which covers obesity medications only if they are approved and prescribed for an additional health benefit.
The approval also supports growing evidence that there may be other health benefits associated with GLP-1s, a class of weight loss and diabetes treatments that have risen and fallen in popularity over the past year. It is worth noting that Zepbound's main competitor is the weight loss drug Wegovy Novo Nordisknot approved for OSA.
Zepbound could be a valuable new treatment option for patients with obstructive sleep apnea (OSA), which can lead to loud snoring and excessive daytime sleepiness, and can contribute to serious complications including stroke and heart failure. Patients with this condition have limited treatment options outside of wearing masks attached to cumbersome machines that provide positive airway pressure, or PAP, to allow normal breathing.
Eli Lilly in April released preliminary results from two clinical trials, which showed Zepbound was more effective than placebo in reducing the severity of sleep apnea in obese patients after a year.
In June, Eli Lilly released additional data from studies that showed Zepbound helped
OSA resolved in approximately half of patients. The first study examined weekly injections in adults with moderate to severe obstructive sleep apnea (OSA) and obesity who were not on PAP treatment. The second Zepbound was tested in adults with the same conditions, but those participants were receiving treatment and planned to continue PAP treatment.
The data showed that 43% of people in the first study and 51.5% of patients in the second trial who took the highest dose of Zepbound achieved “remission of the disease,” according to the company. This compares to 14.9% and 13.6% of patients who took placebo in the two trials, respectively.
The researchers arrived at these conclusions by examining the apnea-hypopnea index, or AHI, which records the number of times per hour that a person's breathing shows a constricted or completely blocked airway. The index is used to evaluate the severity of obstructive sleep apnea and the effectiveness of treatments for this condition.
Resolution of obstructive sleep apnea (OSA) is defined as a patient experiencing fewer than five AHI events per hour, the company said. It's also defined as someone who has between 5 and 14 AHI events per hour and scores a certain number on a standard survey designed to measure excessive daytime sleepiness, according to Eli Lilly.
