The U.S. Food and Drug Administration (FDA) has made a significant advancement in the treatment of obstructive sleep apnea (OSA) by approving a new medication called Zepbound, specifically designed for individuals who are moderately or severely obese. This approval, granted late Friday, is a notable milestone as it is the first medication approved for treating OSA, a condition affecting millions of Americans.
Zepbound is intended to be used alongside a reduced-calorie diet and increased physical activity. Clinical trials conducted by Eli Lilly, the drug’s manufacturer, demonstrated that Zepbound was approximately five times more effective than a placebo in reducing episodes of breathing interruptions in adults not using positive airway pressure therapy. Additionally, for those using such therapy, the drug resulted in an impressive reduction of 29 breathing disruptions per hour, compared to just six with the placebo.
Weight loss was another significant finding in the trials. Participants using Zepbound alongside positive airway pressure therapy lost about 45 pounds on average, versus just 4 pounds for those using a placebo. For individuals who did not use positive airway pressure therapy, the results were even more pronounced, with an average weight loss of 50 pounds for those on Zepbound compared to only 6 pounds for placebo users.
Patrik Jonsson, executive vice president and president of Lilly Cardiometabolic Health, emphasized the urgency of addressing OSA, stating that many cases remain undiagnosed and untreated. He highlighted that Zepbound not only improves the condition but also assists with long-term weight loss. Remarkably, nearly half of the clinical trial participants experienced such significant improvements that they no longer exhibited OSA symptoms, underscoring the drug’s potential to alleviate health challenges linked to this disorder.
Sally Seymour, M.D., who oversees FDA’s division focused on Pulmonology and Critical Care, recognized the approval as a major step forward for patients struggling with sleep apnea. It is estimated that over 33 million Americans rely on Continuous Positive Airway Pressure (CPAP) machines to manage this condition, which is more prevalent among older adults, men, and those who are overweight.
Eli Lilly reports that Zepbound operates through hormone receptors to facilitate weight loss in overweight and obese individuals. However, like many medications, it may come with side effects, particularly gastrointestinal issues, as noted by the manufacturer.
Overall, the approval of Zepbound presents a hopeful development for those suffering from obstructive sleep apnea and obesity, offering a new approach to managing their health and improving their quality of life. With continued awareness and treatment options, there is potential for significant strides in addressing this widespread health issue.