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Weight Loss Drug Tirzepatide Now Approved For Sleep Apnea In Adults With Obesity
The approval was based on the results of the SURMOUNT-OSA trial, which found patients had fewer breathing disruptions.
Tirzepatide (Zepbound) has gained another approval, now as the first and only prescription drug for moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. The drug is recommended to be used alongside a reduced-calorie diet and increased physical activity.
Tirzepatide's approval for moderate-to-severe obstructive sleep apnea in adults with obesity was based on the results of the SURMOUNT-OSA trial.
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Tirzepatide was first approved for chronic weight management slightly more than a year ago. Since then, demand for the glucagon-like peptide 1 has skyrocketed, causing a temporary drug shortage, which was resolved.
The approval was based on the data from the SURMOUNT-OSA trial, a multicenter, randomized, double-blind parallel, placebo-master protocol comparing tirzepatide to placebo.
"Too often, OSA is brushed off as 'just snoring'—but it's far more than that," Julie Flygare, JD, president and CEO of Project Sleep, said in a statement.1 "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."
The results of the SURMOUNT-OSA trials were published in the New England Journal of Medicine. The phase 3 trials evaluated tirzepatide 10 mg or 15 mg compared with placebo in patients with or without positive airway pressure (PAP) therapy. In adults on PAP, tirzepatide resulted in 29 fewer breathing disruptions per hour vs 6 for placebo. For adults not on PAP, they had 25 fewer breathing disruptions per hour on tirzepatide vs 5 with placebo.
Adults on tirzepatide without PAP therapy lost an average of 45 pounds or 18% of their body weight. Those on tirzepatide with PAP therapy lost an average of 50 pounds or 20% of their body weight. In comparison, patients on placebo without PAP lost 4 pounds or 2% of body weight, and those on placebo with PAP lost 6 pounds or 2% of body weight.
"Today, many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences," said Patrik Jonsson, executive vice president, and president of Lilly Cardiometabolic Health and Lilly USA. "Zepbound is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity. Nearly half of clinical trial patients saw such improvements that they no longer had symptoms associated with OSA, marking a critical step forward in reducing the burden of this disease and its interconnected health challenges."
Tirzepatide is also being studied for heart failure with preserved ejection fraction. Data from the SUMMIT trial were recently presented at the American Heart Association Scientific Sessions, showing the drug reduced the risk of cardiovascular death or heart failure worsening by 38%.5
References
1. FDA approves Zepbound (tirzepatide) as the first and only prescription medicine for moderate-to-severe obstructive sleep apnea in adults with obesity. Eli Lilly. News release. December 20, 2024. Accessed December 20, 2024. Https://investor.Lilly.Com/news-releases/news-release-details/fda-approves-zepboundr-tirzepatide-first-and-only-prescription
2. Joszt L. FDA approves diabetes drug tirzepatide for chronic weight management. AJMC. November 8, 2023. Accessed December 20, 2024. Https://www.Ajmc.Com/view/fda-approves-diabetes-drug-tirzepatide-for-chronic-weight-management
3. McCormick B. 5 essential drugs currently facing shortages. AJMC. November 1, 2024. Accessed December 20, 2024. Https://www.Ajmc.Com/view/5-essential-drugs-currently-facing-shortages
4. Melillo G. FDA approves Eli Lilly's Tirzepatide for T2D. AJMC. May 13, 2022. Accessed December 20, 2024. Https://www.Ajmc.Com/view/fda-approves-eli-lilly-s-tirzepatide-for-t2d
5. Caffrey M. For obesity and HFpEF, tirzepatide cuts risk of CV death or worsening HF by 38%. AJMC. November 16, 2024. Accessed December 20, 2024. Https://www.Ajmc.Com/view/for-obesity-and-hfpef-tirzepatide-cuts-risk-of-cv-death-or-worsening-hf-by-38-
Lilly's Weight-loss Treatment Zepbound Becomes First FDA-approved Drug For Sleep Apnea
WASHINGTON — The U.S. Food and Drug Administration on Friday approved Eli Lilly's weight-loss treatment, Zepbound, for obstructive sleep apnea, making it the first drug to get the green light to directly treat patients with the common sleeping disorder.
The regulator approved the drug for moderate to severe obstructive sleep apnea in adults with obesity, the company said.
The approval opens up a wide market of patients for Lilly at a time when demand for Zepbound is already surging.
It could also strengthen Lilly's case with commercial insurers and employers, who have previously hesitated to cover the drug due to its high cost.
Shares of the Indianapolis-based drugmaker were up 1.14% in after-market trading following the announcement.
Sleep apnea patients stop breathing briefly while sleeping, disturbing the sleep cycle and causing long-term complications such as heart conditions. The condition affects roughly one billion people globally.
"Too often, obstructive sleep apnea is brushed off as 'just snoring' — but it's far more than that," said Julie Flygare, CEO of nonprofit organization Project Sleep.
Common treatments for the condition include CPAP machines, which involve wearing a mask over the face while sleeping, surgery, as well as losing weight.
Zepbound and Lilly's widely used diabetes drug, Mounjaro, both chemically called tirzepatide, belong to a class of drugs called GLP-1 agonists.
Originally developed for Type 2 diabetes, they also reduce food cravings and cause the stomach to empty more slowly.
U.S.-based Lilly and Danish rival Novo Nordisk are testing their blockbuster obesity drugs for a range of conditions as they race to show that they have other health benefits.
Regulators can expand approval for medicines if new data shows them to be effective in other therapeutic areas.
The FDA's approval is based on data from two trials involving 469 participants, in which Zepbound helped ease breathing difficulties in patients with moderate to severe obstructive sleep apnea.
The drugmaker published the full data in June, showing the drug helped resolve the disorder in up to 52% of patients in these trials.
Trial data also showed that Zepbound lowered the so-called biomarkers of sleep apnea, including low blood oxygen and blood pressure, which can indicate heart disease.
Government-backed Medicare plans for adults aged 65 and older and those with disabilities are barred from covering weight-loss treatments, though the Biden administration has proposed to expand the coverage of anti-obesity drugs.
If President-elect Donald Trump's incoming administration backs the move, the program will be effective in 2026.
Medicare only began covering Novo Nordisk's Wegovy after it gained approval for reducing the risk of heart attacks and strokes in March.
Contributing: Sriparna Roy and Patrick Wingrove
Sleep Apnea Might Change Brain, Speed Aging
Sleep apnea is known to wreak havoc on the body and also appears to have direct effects on brain health, a new study shows. Photo by Adobe Stock/HealthDay News
Sleep apnea is known to wreak havoc with the body, contributing to heart problems, diabetes and liver disease.
The sleep disorder also appears to have direct effects on brain health, a new study shows.
People with sleep apnea appear to experience accelerated aging of the brain's white matter, which serves to connect the various regions of the brain, researchers reported Wednesday in the journal Neurology.
Sleep apnea also is associated with an increase in the size of the hippocampus, the part of the brain responsible for memory and thinking, researchers said.
"Both brain shrinkage and brain growth can harm memory and thinking by disrupting normal brain functions, increasing the risk of cognitive decline and dementia," lead researcher Dr. Alberto Ramos, a neurologist and sleep medicine specialist with the University of Miami, said in a news release from the school.
People with sleep apnea stop breathing while asleep. This causes their brain to jolt them to wakefulness, at least enough for them to resume breathing.
Over time, untreated sleep apnea can increase a person's risk of developing heart disease, Type 2 diabetes, fatty liver disease and mood disorders, according to the Sleep Foundation.
But researchers suspected that sleep apnea might do damage to the brain as well, Ramos said.
"Some studies have found sleep problems and lower oxygen levels during sleep have been linked to brain shrinkage while others have found a link to brain growth," he noted.
For this study, researchers tracked the health of nearly 2,700 Hispanic seniors with an average age of 68.
"Our study looked at Latino people, who have a higher risk of dementia when compared to non-Latino White people," Ramos said.
The participants all had a take-home sleep test that measured the number of sleep disruptions they experienced.
About 56% of the people had no sleep problems, compared to 28% who had mild sleep problems and 16% who had moderate to severe sleep problems.
Brain scans taken 10 years after the sleep test showed that those with the most sleep problems had greater brain volume in the hippocampus, results show.
In fact, the size of the hippocampus increased with the number of sleep disruptions a person experienced, researchers said.
Lower oxygen levels during sleep were also associated with increase hippocampal volume, as well as changes in white matter.
"Our findings highlight the complex relationships between sleep health and brain aging and show there is a need for longer studies that follow people beginning in middle age or earlier," Ramos said.
"A clear understanding of how brain volume is affected by sleep apnea and other sleep disorders is essential so people can receive early and effective treatment, especially in people who may be at higher risk for dementia," Ramos concluded.
More information
The National Sleep Foundation has more on sleep apnea.
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