Many people who struggle with sleep apnea now have a new way to help them sleep more soundly. This month, the Food and Drug Administration expanded the approval of Eli Lilly’s obesity drug Zepbound to explicitly cover sleep apnea.
On Friday, the FDA officially approved Zepbound as a treatment for moderate to severe obstructive sleep apnea in adults with obesity. In two large-scale clinical trials, the drug successfully helped people lose weight and reduce their apnea symptoms. Zepbound is now the first prescription medication approved for obstructive sleep apnea, a condition that affects about 12% of Americans.
Apnea it happens when our bodies temporarily stop breathing during sleep, which causes the brain to wake the person up just enough to start breathing again, only for the cycle to restart once the person falls asleep. The more severe a person’s apnea, the more these episodes of stopped or reduced breathing occur in a night (but not always associated with apnea, snoring is a sign of having a narrow airway while sleeping). Obstructive sleep apnea, or OSA, is caused by physical blockage of the airway muscles and is by far the most common form of sleep apnea.
While there are many risk factors for OSA, obesity is known to be a particularly major contributor. The active ingredient in Zepbound, tirzepatide, has proven very effective in treating obesity, with people losing more than 20% of their body weight in trials. So Eli Lilly wanted to test whether the drug could also effectively treat apnea.
Across both processestirzepatide performed as expected in outperforming a placebo. People lost between 18% and 20% of their body weight. On average, the drug also reduced the frequency of apnea episodes by up to two-thirds, with participants having about 30 fewer episodes per hour. And up to 50% of people who take tirzepatide have no symptoms after a year.
“Today’s approval marks the first drug treatment option for some patients with obstructive sleep apnea,” said Sally Seymour, director of the Division of Pulmonology, Allergy and Critical Care at the Center for Evaluation and Research of FDA drug, in a declaration announcing FDA approval. “This is a big step forward for patients with obstructive sleep apnea.”
There are already other highly effective treatments for apnea, particularly continuous positive airway pressure (CPAP) machines. So CPAP will remain a gold standard option for many, especially for those with apnea who are not obese. But CPAP machines require daily use at night, which may be too cumbersome for some people to tolerate long-term. By contrast, the weekly injection required to take Zepbound could be much more convenient for some eligible patients. In clinical trials, people taking Zepbound and CPAP saw even better results than any other group, highlighting the possible benefits of combined therapy.
Zepbound and similar GLP-1 drugs are not completely without problems, however. Its most common side effects include vomiting, diarrhea and other gastrointestinal symptoms. These drugs aren’t cheap either, with list prices running over $1,000 a month. But the expanded approval should make it easier for some people to secure insurance coverage for Zepbound, and just having more interventions available for apnea is invaluable. As with obesity, this approval could open a new era for the treatment of sleep apnea.
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2024-12-23 18:05:00
