The weight-loss drug Zepbound (tirzepatide) now has another major benefit: on Dec. 20, it became the first drug approved by the U.S. Food and Drug Administration (FDA) to treat obstructive sleep apnea.
In the trial that Lilly, the drug’s manufacturer, submitted in April to the FDA, scientists reported that the drug helped people who were overweight or obese with sleep apnea reduce a standard measure of restricted breathing by 63%, leading to 30 fewer interrupted sleep events a night on average compared to those given a placebo. The study, which followed people for a year, included two analyses; one involved people who took only Zepbound and were compared to a placebo group, and another had people take Zepbound paired with a positive airway pressure (PAP) device, which is currently one of the standard treatments for obstructive sleep apnea. That group was compared to one taking a placebo and using PAP.
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“This is the first pharmacologic therapy that can treat obstructive sleep apnea in this way,” says Dan Skovronsky, chief scientific officer at Eli Lilly.
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The new indication applies to people who are overweight or obese and have a specific type of sleep apnea known as obstructive sleep apnea, which is a physical condition in which the muscles of the throat relax and block air passages. (Another type, called central sleep apnea, occurs when the brain doesn’t send the proper messages to the respiratory system to regulate breathing.) Excess fat tissue can contribute to this collapse of the airway, so by helping people lose weight, Zepbound reduces the number of times people’s breathing becomes obstructed. “We hypothesized, and now have proven, that when you treat with tirzepatide, you remove some fat and the airway can stay open,” says Skovronsky.
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In the study that informed the drug’s approval, people who used both Zepbound and PAP reported fewer interruptions overall in breathing compared to those using Zepbound alone—but Skovronsky notes that the two analyses involved different groups of people, with those using PAP likely experiencing more severe sleep apnea than those who didn’t require PAP.
It’s likely true that many people with obesity and sleep apnea who are already taking Zepbound are benefiting from fewer episodes of restricted breathing, but the formal indication from the FDA should help more doctors and patients treat both conditions more effectively, Skovronsky says. Other studies conducted by Lilly show that the drug can also reduce the progression of heart failure and kidney disease.
“Obstructive sleep apnea is still poorly diagnosed,” Skovronsky says. “But this is a disease that itself carries cardiovascular risk, as does obesity, so it’s great to treat both.”