An Eli Lilly & Co. Zepbound injection pen placed in the Brooklyn borough of New York, U.S., on Thursday, March 28, 2024.
Shelby Knowles | Bloomberg | fake images
The Food and Drug Administration on Friday approved Eli LillyZepbound's blockbuster weight loss drug, Zepbound, to treat patients with the most common sleep-related breathing disorder, expanding its use and possibly its insurance coverage in the US.
The weekly injection is now the first approved drug treatment option for patients with obesity and moderate to severe obstructive sleep apnea (OSA), which refers to interrupted breathing during sleep due to a narrowing or blockage of the airways. Zepbound should be used in combination with a low-calorie diet and increased physical activity, the FDA said in a statement.
An estimated 80 million patients in the United States suffer from the disease, according to Eli Lilly. 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 considered 'just snoring,' but it's much more than that,” said Julie Flygare, president and CEO of Project Sleep, a nonprofit organization that advocates for sleep health and disorders. , in a statement from Eli Lilly. “It's important to understand the symptoms of OSA and know that treatments are available, including new options like Zepbound. We hope this will spark more meaningful conversations between patients and healthcare providers and ultimately lead to better health outcomes “.
Eli Lilly hopes to launch the OSA drug early next year. It is the first approval beyond obesity treatment for Zepbound, which entered the market late last year and is also being tested for other obesity-related conditions, such as fatty liver disease. Tirzepatide, the active ingredient in Zepbound, has been sold on the U.S. market longest as the diabetes drug Mounjaro.
The agency's decision could pave the way for Eli Lilly to get broader insurance coverage for Zepbound, which, like other weight-loss drugs, is not covered by many insurance plans. That includes the federal Medicare program, which only covers obesity medications if they are approved and prescribed for an additional health benefit.
The approval also supports growing evidence that there may be more health benefits associated with GLP-1s, a class of weight loss and diabetes treatments that have skyrocketed in popularity and suffered shortages over the past year. In particular, Zepbound's main rival, the weight loss drug Wegovy from NordiskIt is 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 can contribute to serious complications such as stroke and heart failure. Patients with this condition have limited treatment options other than using masks connected to cumbersome machines that provide positive airway pressure, or PAP, to allow normal breathing.
Eli Lilly published initial results from the two clinical trials in April, which showed that 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 studies showing that Zepbound helped
resolve OSA in almost half of patients. The first study examined weekly injection in adults with moderate to severe OSA and obesity who were not on PAP therapy. The second tested Zepbound in adults with the same conditions, but those participants were and planned to continue on PAP therapy.
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 “disease resolution,” according to the company. That compares with 14.9% and 13.6% of patients who took a placebo in the two trials, respectively.
The researchers reached those conclusions by examining an apnea-hypopnea index, or AHI, which records the number of times per hour that 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.
OSA disease resolution is defined as a patient having fewer than five AHI events per hour, the company said. It is also defined as a person who has five to 14 AHI events per hour and scores a certain score on a standard survey designed to measure excessive daytime sleepiness, according to Eli Lilly.
