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Weekly injection now. cleaned up For obese and moderately severe patients Obstructive sleep apneaor OSA, which refers to obstructive breathing during sleep due to narrowed or blocked airways.
According to Eli Lilly, an estimated 80 million patients in the United States experience this disease. About 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.
“Oftentimes, OSA is dismissed as ‘just snoring’ — but it’s so much more than that,” said Julie Flyger, president and CEO of Project Sleep, which promotes sleep health and sleep. Eli Lilly, a nonprofit advocacy organization, said in a release. “It’s important to understand the symptoms of 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, better health outcomes.” will lead to better results.”
Eli Lilly expects to launch the drug for OSA early next year. This is the first approval outside of obesity treatment for ZipBound, 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 long been marketed in the U.S. as the diabetes drug Mounjaro.
The agency’s decision could pave the way for Eli Lilly to gain broader insurance coverage for Zipbound, which, like other weight-loss drugs, is not covered by many insurance plans. This includes the federal Medicare program, which only covers obesity drugs if they are approved and prescribed for an additional health benefit.
The approval also supports growing evidence that there may be additional health benefits associated with GLP-1s, a class of weight-loss and diabetes treatments that have grown in popularity over the past year. They have become scarce during Specifically, from Zepbound’s main competitor, the weight loss drug Wegovy Novo Nordiskis not approved for OSA.
Zip-bound may be a valuable new treatment option for patients with OSA, which can lead to loud snoring and excessive daytime sleepiness, and can contribute to serious complications including stroke and heart failure. is Patients with this condition have limited treatment options outside of wearing a mask attached to cumbersome machines that provide positive airway pressure, or PAP, for breathing.
Eli Lilly released preliminary results from two clinical trials in April, which showed that Zipbound was more effective than placebo in reducing the severity of OSA in obese patients after one year.
In June, Eli Lilly released additional data from studies showing that Zipbound helped.
OSA resolves in about half of patients. The first study examined weekly injections in adults with moderate to severe OSA and obesity who were not on PAP therapy. Others tested zip-bound in adults with similar conditions, but those participants were on and planned to continue PAP therapy.
Data showed that 43 percent of people in the first study and 51.5 percent of patients in the second trial who took the highest dose of Zipbound achieved “disease resolution,” according to the company. This compares with 14.9% and 13.6% of patients who took placebo in the two trials, respectively.
The researchers arrived at the findings by evaluating the apnea-hypopnea index, or AHI, which measures how many times a person breathes each hour with a restricted or completely blocked airway. The index is used to assess the severity of obstructive sleep apnea and the effectiveness of treatment for the condition.
Disease resolution for OSA is defined as a patient having fewer than five AHI events per hour, the company said. According to Eli Lilly, it is also defined as a person having five to 14 AHI events per hour and achieving a certain number on a standardized survey that is excessive daytime sleepiness. Designed to measure