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

The Food and Drug Administration on Friday approved Eli Lilly‘s blockbuster weight loss drug Zepbound for treating patients with the most common sleep-related breathing disorder, expanding its use and possibly its insurance coverage in the U.S.

The weekly injection is now the first drug treatment option cleared for patients with obesity and moderate-to-severe obstructive sleep apnea, or OSA, which refers to breathing interrupted during sleep due to narrowed or blocked airways. Zepbound should be used in combination with a reduced-calorie diet and increased physical activity, the FDA noted in a release.

An estimated 80 million patients in the U.S. experience the disease, according to Eli Lilly. Roughly 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 brushed off as ‘just snoring’ — but it’s far more than that,” said Julie Flygare, president and CEO of Project Sleep, a nonprofit advocating for sleep health and sleep disorders, in a release from Eli Lilly. “It’s important to understand OSA symptoms and know that treatments are available, including new options like Zepbound. We hope this will spark more meaningful conversations between patients and health care providers and ultimately lead to better health outcomes.” 

Eli Lilly expects to launch the drug for OSA at the beginning of next year. It 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 fatty liver disease. Tirzepatide, the active ingredient in Zepbound, has been sold on the U.S. market for longer as the diabetes drug Mounjaro.

The agency’s decision could pave the way for Eli Lilly to gain broader insurance coverage for Zepbound, which, like other weight loss drugs, is not covered by many insurance plans. That includes the federal Medicare program, which only covers obesity drugs if they are approved and prescribed for an added health benefit.

The approval also backs up mounting evidence that there could be further health benefits tied to GLP-1s, a class of weight loss and diabetes treatments that have soared in popularity and slipped into shortages over the past year. Notably, Zepbound’s main rival, the weight loss drug Wegovy from Novo Nordisk, is not approved for OSA.

Zepbound could 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. Patients with the condition have limited treatment options outside of wearing masks hooked up to cumbersome machines that provide positive airway pressure, or PAP, to allow for normal breathing.

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