FDA approves Eli Lilly’s weight-loss drug Zepbound for treatment of sleep apnea

The Food and Drug Administration approved Friday Elie LillyZepbound, ‘s blockbuster weight loss drug, aimed at treating 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 approved drug treatment option for patients with obesity and moderate to severe obstructive sleep apnea, or OSA, which refers to interrupted breathing during sleep due to narrowing or blockage of the airways. Zepbound should be used in combination with a low-calorie diet and increased physical activity, the FDA noted in a statement.

In the United States, approximately 80 million patients suffer from this disease, according to Eli Lilly. 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.

“Too often, OSA is thought of as just snoring, but it’s much more than that,” said Julie Flygare, president and CEO of Project Sleep, a nonprofit organization that advocates for health and disorders. sleep, in a press release 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 plans to launch the OSA drug early next year. This is the first approval beyond obesity treatment for Zepbound, which entered the market late last year and is also being tested for several other obesity-related conditions, such as hepatic steatosis. Tirzepatide, the active ingredient in Zepbound, has been sold in the U.S. market for the longest time under the name Mounjaro, a diabetes drug.

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 only covers obesity medications if they are approved and prescribed for an additional health benefit.

The approval also confirms growing evidence that GLP-1s may have other health benefits, a class of treatments for weight loss and diabetes that has gained popularity and fallen into shortage over the past year. the past year. Notably, Zepbound’s main rival, the weight loss drug Wegovy from Novo Nordiskis not approved for OSA.

Zepbound could provide a valuable new treatment option for patients suffering from 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 disease have limited treatment options aside from wearing masks attached to bulky machines that provide positive airway pressure, or PAP, to allow normal breathing.

Eli Lilly released initial results from two clinical trials in April, which showed that Zepbound was more effective than a placebo in reducing the severity of OSA in obese patients 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 the 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 these participants were taking and planning 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 “disease resolution,” according to the company. This compares to 14.9% and 13.6% of patients who took a placebo in the two trials, respectively.

Researchers came to these conclusions by looking at an apnea-hypopnea index, or AHI, which records the number of times per hour a person’s breathing shows a restricted or completely blocked airway. The index is used to assess the severity of obstructive sleep apnea and the effectiveness of treatments for this condition.

Disease resolution for OSA is defined as a patient experiencing fewer than five AHI events per hour, the company said. It’s also defined as someone having five to 14 AHI events per hour and scoring a certain number on a standard survey designed to measure excessive daytime sleepiness, according to Eli Lilly.