FDA approves weight loss drug Zepbound for obstructive sleep apnea

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

The drug, part of the class known as GLP-1 receptor agonists, which also includes Ozempic, was approved to treat moderate to severe forms of the sleep disorder in people with obesity. It should be used in conjunction with a reduced-calorie diet and increased physical activity, drugmaker Eli Lilly said in a news release.

Obstructive sleep apnea or OSA, affects as many as 30 million people in the United States and is closely associated with obesity, according to to the American Academy of Sleep Medicine, which notes that losing weight can reduce its severity. It is characterized by breathing disorders during sleep caused by blocked airflow and increases the risk of heart and brain problems.

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

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

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

Although the new green light from the FDA does not expand the number of people who may be eligible for the drug, since the sleep apnea approval is specific to people with obesity, it could lead to insurance coverage for those with the condition on Medicare, which does not cover medication solely for weight loss.

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

The Biden administration proposed in November to change Medicare’s coverage policy for obesity drugs, but currently Medicare beneficiaries can get coverage for weight loss drugs only when they are used for another indication, such as reducing heart risks.

The FDA approval for sleep apnea is based on two company sponsors attempt involving about 470 participants, one in which patients were treated with continuous positive airway pressure or CPAP machines, one mainstay of treatment that helps keep the airways open.

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

The trials’ main goal was improvement in a metric known as the apnea-hypopnea index, or AHI, the number of breathing interruptions during one hour of sleep. In both studies, the mean AHI at baseline was about 50 events per hour, and the patients had an average body mass index, or BMI, of about 39; obesity is characterized as a BMI of 30 or more.

In the trial in which patients did not use CPAP machines, those using Zepbound had about 25 fewer AHI respiratory events per hour on average after one year of treatment, compared with a reduction of about five for those given placebo. In the trial where patients were on CPAP machines, those on Zepbound had about 29 fewer events per hour compared to about six for those on placebo.

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

Patients on the drug also saw reductions in blood pressure and inflammation, “important risk factors for cardiovascular complications of 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 occurred mostly during the period when patients were just starting the medication or increasing their dose.