On Thursday, March 28, 2024, Eli Lilly and Company’s Zepbound injection pen was installed in Brooklyn, New York, USA.
Shelby Knowles | Bloomberg | Getty Images
FDA Approved Eli Lilly and Companyblockbuster weight loss pill Zepp Bond The drugmaker announced Friday that it is expanding its use in the U.S. and may expand its insurance coverage for patients with the most common sleep-related breathing disorder.
Now injected once a week cleared Suitable for patients with moderate to severe obesity obstructive sleep apneaor OSA, refers to interruptions in breathing during sleep due to narrowing or obstruction of the airways.
An estimated 80 million patients in the United States have the disease, according to Eli Lilly and Company. The company told CNBC earlier this year that about 20 million of them have moderate to severe disease, but 85% of cases go undiagnosed.
“OSA is often thought of as ‘just snoring,’ but it’s much more than that,” Julie Flygare, president and CEO of Project Sleep, a nonprofit organization that advocates for sleep health and sleep disorders, said in a press release from Eli Lilly and Company. “It’s important to understand OSA symptoms and understand the treatments 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 expects to launch a drug for OSA early next year. This is the first approval outside of obesity treatment 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. Zepbound’s active ingredient, Tirzepatide, has been marketed in the U.S. longer 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. These include the federal Medicare program, which only covers weight loss drugs that are approved and prescribed for added health benefits.
The approval also supports growing evidence that GLP-1, a class of weight-loss and diabetes treatments that has surged in popularity over the past year but has fallen into shortages, may offer additional health benefits. . It is worth noting that Zepbound’s main competitor is the weight loss drug Wegovy Novo Nordisknot approved for use in OSA.
Zepbound could be a valuable new treatment option for patients with OSA, which causes loud snoring and excessive daytime sleepiness and can lead to serious complications such as stroke and heart failure. Patients with the disease have limited treatment options beyond wearing a mask and being connected to a bulky machine that provides positive airway pressure (PAP) for normal breathing.
Eli Lilly released preliminary results from both clinical trials in April, showing that Zepbound was more effective than placebo in reducing the severity of OSA in obese patients after one year.
In June, Eli Lilly released more research data showing that Zepbound helps
Nearly half of the patients experienced remission of OSA. The first study examined weekly injections in adults with moderate to severe OSA and obesity who were not receiving PAP therapy. The second test tested Zepbound in adults with the same condition, but these participants were on and planned to continue PAP treatment.
The company said data showed that 43% of patients in the first study and 51.5% of patients in the second trial who took the highest dose of Zepbound achieved “disease remission.” This compares with 14.9% and 13.6% of patients taking placebo in the two trials.
The researchers reached these conclusions by examining the apnea-hypopnea index (AHI), which records the number of times per hour a person’s breathing reveals airway restriction or complete obstruction. This index is used to assess the severity of obstructive sleep apnea and the effectiveness of treatments for the condition.
OSA disease resolution is defined as patients experiencing fewer than five AHI events per hour, the company said. According to Eli Lilly, it is also defined as someone who experiences between five and 14 AHI events per hour and scores a certain score on a standard survey designed to measure excessive daytime sleepiness.
About The Author
