CNN
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The U.S. Food and Drug Administration on Friday approved the first prescription drug for obstructive sleep apnea: the weight-loss drug Zepbound.

The drug belongs to the class of GLP-1 receptor agonists, which includes Ozempic, and has been approved to treat moderate to severe forms of sleep disorder in people with obesity. It should be taken with a reduced-calorie diet and increased physical activity, drug maker Eli Lilly said in a news release.

According to the American Academy of Sleep Medicine, obstructive sleep apnea (OSA) affects up to 30 million people in the United States and is closely linked to obesity. It is characterized by difficulty breathing during sleep caused by blocked airflow and increases the risk of heart and brain problems.

“Many cases of OSA go undiagnosed and untreated, putting millions of people at risk of serious health consequences,” said Patrik Jonsson, president of Lilly Cardiometabolic Health, in the company’s press release. Symptoms include snoring or wheezing during sleep and excessive daytime sleepiness.

Jonsson noted that Lilly’s clinical trials showed that nearly half of participants “saw such improvements that they no longer had symptoms associated with OSA.”

The approval is the second indication for Zepbound, which was approved in November 2023 for weight loss in people who are obese or overweight and have weight-related health problems.

Although the FDA’s new green light does not increase the number of people who may be eligible for the drug, it could lead to coverage for those with the condition through Medicare, since the sleep apnea approval is specifically for people with obesity, However, medications used solely for weight loss are not covered.

Without insurance, Zepbound costs $1,060 a month, but Lilly offers discounts, coupons and a cheaper version that comes in a vial that patients inject with a syringe instead of an auto-injector pen. Still, out-of-pocket costs can be hundreds of dollars each month.

The Biden administration in November proposed changing Medicare’s coverage policy for obesity drugs. However, currently, Medicare enrollees can only get coverage for weight loss drugs if they are used for another indication, such as reducing heart risks.

FDA approval for sleep apnea is based on two company-sponsored studies involving approximately 470 participants. In one, patients were treated with continuous positive air pressure (CPAP) machines, a mainstay of treatment that helps keep the airways open.

Treatment with Zepbound, whose generic name is tirzepatide, led to improvements in both groups of patients, results published in June in the New England Journal of Medicine showed.

The main goal of the studies was to improve a measure known as the apnea-hypopnea index (AHI), which measures the number of breathing disorders during an hour of sleep. In both studies, mean baseline AHI was approximately 50 events per hour, and patients had an average body mass index (BMI) of approximately 39; Obesity is characterized by a BMI of 30 or more.

In the study in which patients did not use CPAP machines, those who used Zepbound experienced, on average, about 25 fewer AHI breathing events per hour after one year of treatment, compared to a reduction of about five in those who did received placebo. In the study where patients received CPAP machines, Zepbound patients experienced about 29 fewer events per hour, compared to about six fewer events per hour for placebo patients.

Participants on Zepbound also lost significant amounts of weight: an average of about 18% of their body weight in the first trial and about 20% in the second, compared to 1.6% and 2.3%, respectively, for participants on placebo. That’s an average of 45 to 50 pounds of weight loss over a year, Lilly said.

Patients taking the drug also noted reductions in blood pressure and inflammation, “important risk factors for cardiovascular complications in obstructive sleep apnea with obesity,” researchers wrote in the New England Journal of Medicine.

The most common side effects were gastrointestinal events, which were typically mild to moderate, the researchers said, and most often occurred around the time patients were just starting to take the drug or increasing their dose.