The Food and Drug Administration on Friday approved Eli Lilly's weight-loss drug Zepbound as a treatment for moderate-to-severe sleep apnea and obesity.
Zepbound is the first medication approved to treat patients with obstructive sleep apnea, said Sally Seymour, the FDA's director of the division of pulmonology, allergy and critical care. The FDA said the popular weight-loss drug should be combined with a reduced-calorie diet and increased physical activity.
Obstructive sleep apnea happens when a person's upper airway becomes blocked and pauses breathing during sleep. The condition happens more often in people who are overweight or have obesity. Symptoms can include snoring, fatigue, daytime sleepiness and disrupted sleep.
Sleep apnea can significantly increase health risks, even the risk of death, so doctors strongly recommend people address it.
But standard therapy with breathing devices known as CPAPs are not hugely popular with patients. Studies suggest that one-third to half of apnea patients either quit using a continuous positive airway pressure machine or never fill their prescription for it.
One manufacturer was forced to pay a large settlement earlier this year after it recalled a number of CPAP devices.
The FDA said Zepbound's approval for moderate to severe obstructive sleep apnea in adults with obesity is based on two placebo-controlled studies of 469 adults without type 2 diabetes. One study group received the standard treatment of positive airway pressure while another study included people who did not use PAP machines.
Participants in both studies received a weekly dose of 10 or 15 milligrams of Zepbound or placebo for one year.
Compared to placebo, participants who received the drug had a meaningful drop in the number of times they stopped breathing of had shallow breathing.
Those who took Zepbound also lost more weight than the placebo group after one year. Their symptom improvement was likely thanks to their weight loss, the FDA said.
Zepbound is a glucagon-like peptide 1 drug that reduces appetite and food intake. The drug's active ingredient, tirzepatide, is marketed as Zepbound for weight loss and Mounjaro as a diabetes treatment.
Zepbound's side effects can include nausea, diarrhea, vomiting, constipation, stomach discomfort and pain. Other side effects include fatigue, allergic reactions, burping, hair loss and gastroesophageal reflux disease.
Along with Novo Nordisk's GLP-1 drugs Ozempic and Wegovy, this class of medications has become wildly popular as weight-loss and diabetes medications. Wegovy also has been approved as a treatment to reduce the risk of heart attack and stroke.
Consumer advocates and elected officials have raised concerns about the prices of GLP-1 medications, and many insurance companies, states and employers have limited or restricted coverage for the drugs approved to treat obesity.