FDA approves weight-loss drug Zepbound to treat sleep apnea

The Food and Drug Administration on Friday approved Eli Lilly’s weight-loss drug Zepbound to treat sleep apnea, a common but potentially serious sleep-related breathing disorder, marking it the first medication for certain patients with the condition.

The agency green-lit the blockbuster medication to treat moderate to severe obstructive sleep apnea in adults with obesity in combination with increased physical activity and a reduced-calorie diet.

Obstructive sleep apnea occurs when a person’s upper airway becomes blocked, which can lead to pauses in breathing during sleep. Symptoms include snoring and fatigue, making the condition easily overlooked by doctors. The disorder is common in people who are overweight or obese, although it can affect anyone. Studies show Zepbound can improve the condition by reducing body weight, the FDA said.

The move comes as weight-loss medications have garnered immense national attention and ignited a debate about access and demand for the drugs, which help people shave pounds.

The FDA first approved Zepbound to treat obesity in November 2023. Its active ingredient, tirzepatide, was previously approved as Mounjaro to treat Type 2 diabetes and became popular as an off-label weight-loss treatment.

Tirzepatide works by stimulating two hormones that slow the stomach from emptying and signal a sense of fullness to the brain, suppressing appetite and helping control blood-sugar levels.

Demand for Zepbound and Mounjaro has been so hot that Eli Lilly has struggled to make enough, leading the FDA to place it on a list of drugs in shortage and enabling compounding pharmacies to make cheaper, off-brand copies of it. On Thursday, the FDA officially declared the shortage over, a long-sought victory for Lilly.

Lilly recorded $3 billion in sales from Zepbound in the first nine months of the year, according to a securities filing, making it one of the company’s top-selling drugs.

Sleep apnea has historically been treated with therapies such as the use of a continuous positive airway pressure (CPAP) machine, which delivers air through a mask while a person sleeps. Medicare does not cover weight-loss drugs specifically for obesity, although the medications can be covered for conditions exacerbated by obesity, such as diabetes or heart disease.

“(Friday’s) decision likely opens the door to Medicare coverage of an anti-obesity medication a bit wider than when the FDA approved Wegovy for cardiovascular disease risk reduction early in 2024,” Juliette Cubanski, a deputy director of KFF, a nonpartisan health-care research organization, wrote in an email.

Last month, the Biden administration proposed expanding coverage of weight-loss drugs for millions of people on Medicare and Medicaid, teeing up a clash with the President-elect Donald Trump’s incoming administration, which is charged with deciding whether to finalize the plan.

State Medicaid programs only have to cover these drugs for conditions such as diabetes or heart disease; roughly 13 states also cover the drugs specifically for obesity, according to KFF. The rules have limited who can get these medications because of their cost.