The Food and Drug Administration announced late Friday that it has approved Zepbound to treat obstructive sleep apnea for those who are moderately or severely obese.
The drug is to be used in conjunction with a reduced-calorie diet and physical activity, the FDA said.
Eli Lilly, the maker of Zepbound, stated that the drug was approximately five times more effective than a placebo in reducing breathing disruptions in adults who were not using positive airway pressure therapy. Furthermore, among adults who used positive airway pressure therapy, Zepbound resulted in 29 fewer breathing disruptions per hour in comparison to the 6 disruptions seen with a placebo.
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Eli Lilly also indicated that the drug had a significant effect on weight. Adults on Zepbound combined with positive airway pressure therapy lost an average of 45 pounds, while those on placebo with positive airway pressure therapy lost just 4 pounds. In contrast, adults on Zepbound without positive airway pressure therapy lost an average of 50 pounds, compared to just 6 pounds for those on placebo.
"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."
The FDA noted that this was the first time it has approved a medication to treat obstructive sleep apnea. According to the National Council on Aging, it is estimated that approximately 33 million Americans use Continuous Positive Airway Pressure machines to treat sleep apnea. Older people, men and people who are overweight are more likely to have sleep apnea.
The organization estimates that 33 million Americans use a CPAP machine to treat sleep apnea.
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“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” said Sally Seymour, M.D., director of the division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research. “This is a major step forward for patients with obstructive sleep apnea.”
Eli Lilly says that Zepbound uses hormone receptors to help people who are considered obese or overweight lose weight and keep it off.
Like any medication, Zepbound may have side effects. Eli Lilly noted that Zepbound can be related to numerous adverse gastrointestinal reactions.
