Eli Lilly & Co.’s Zepbound injection pen placed on Thursday, March 28, 2024 in the Brooklyn borough of New York City, USA.
Shelby Knowles | Bloomberg | Getty Images
The Food and Drug Administration approved it on Friday. Eli LillyZepbound, the blockbuster weight loss drug to treat patients with the most common sleep-related breathing disorder, could expand use and insurance coverage in the United States.
Weekly injections are now the first drug treatment option approved for patients with obesity and moderate to severe obstructive sleep apnea (OSA). OSA refers to interruptions in breathing during sleep due to narrowing or obstruction of the airways. The FDA says in a release that Zepbound should be used in conjunction with a reduced-calorie diet and increased physical activity.
According to Eli Lilly, an estimated 80 million people in the United States experience the disease. The company told CNBC earlier this year that about 20 million of them have moderate to severe infections, but 85% of cases are undiagnosed.
“OSA is too often dismissed as ‘just snoring,’ but it’s so much more than just snoring,” said the president and CEO of Project Sleep, a nonprofit organization that advocates for sleep health and sleep disorders. )’s Julie Flieger said in an Eli Lilly release. “It’s important to understand the symptoms of OSA and know there are treatments available, including new options like Zepbound. This will lead to more meaningful conversations between patients and healthcare providers, and ultimately I hope it will lead to better health.”
Eli Lilly plans to launch a drug for OSA early next year. This is the first approval outside of obesity treatment for Zepbound, which came to market late last year and is also being tested in several other obesity-related conditions, including fatty liver disease. Zepbound’s active ingredient, tirzepatide, has long been sold in the U.S. market as the diabetes drug Mounjaro.
The agency’s decision could pave the way for Eli Lilly to gain 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 drugs only if they are approved and prescribed for additional health benefits.
The approval also adds to the growing body of evidence that there may be additional health benefits associated with GLP-1, a type of weight loss and diabetes drug that has soared in popularity and fallen into short supply over the past year. It corroborates this. Of note is Zepbound’s main competitor, the weight loss drug Wegovy. novo nordisknot approved as OSA.
Zepbound could be a valuable new treatment option for patients with OSA, which causes loud snoring and excessive daytime sleepiness, which can lead to serious complications such as stroke and heart failure. Patients with this disease have limited treatment options other than wearing a mask connected to a cumbersome machine that provides positive airway pressure (PAP) to allow normal breathing.
In April, Eli Lilly announced initial results from two clinical trials showing that Zepbound was more effective than a placebo in reducing the severity of OSA in obese patients after one year.
In June, Eli Lilly announced additional research data showing that Zepbound was effective.
OSA resolves in nearly half of patients. The first study looked at weekly injections in adults with moderate to severe OSA and obesity who were not receiving PAP therapy. A second experiment tested Zepbound on adults with the same symptoms, but the participants were on PAP therapy and planned to continue.
The company said its data showed that 43% of patients in the first study and 51.5% of patients in the second study who took the highest dose of Zepbound achieved “disease resolution.” These numbers compare with the 14.9% and 13.6% of patients who took placebo in the two trials, respectively.
Researchers reached this conclusion by looking at the Apnea-Hypopnea Index (AHI), which records the number of times per hour that a person’s breathing indicates airway restriction or complete obstruction. This index is used to assess the severity of obstructive sleep apnea and the effectiveness of treatment for the condition.
According to the company, disease resolution for OSA is defined as a patient having fewer than five AHI events per hour. According to Eli Lilly, this is also defined as someone who experiences 5 to 14 AHI events per hour and scores a certain number on a standardized survey designed to measure excessive daytime sleepiness. It is said that it will be done.
