US FDA Approves First-Ever Drug To Combat Sleep Apnea

The U.S. Food and Drug Administration (FDA) has approved Zepbound, the first prescription medication specifically designed to treat obstructive sleep apnea (OSA). This announcement marks a significant milestone in the management of OSA, a condition that affects approximately 30 million Americans.

Zepbound, part of the GLP-1 receptor agonist class of drugs that includes popular medications like Ozempic, was cleared on December 20 for treating moderate to severe OSA in people with obesity. The medication, manufactured by Eli Lilly, is intended to be used alongside a reduced-calorie diet and increased physical activity.

“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” stated Dr Sally Seymour, 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.”

What Is Obstructive Sleep Apnea?

OSA is repeated interruptions in breathing during sleep due to blocked airflow. It can lead to severe health complications, including cardiovascular disease, daytime fatigue, and impaired cognitive function. Weight loss has long been considered an effective strategy to reduce the severity of OSA, making Zepbound’s dual impact on weight and sleep apnea symptoms particularly promising.

“Many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences,” said Patrik Jonsson, president of Lilly Cardiometabolic Health.

Clinical Trials Show Promising Results

The FDA’s approval of Zepbound for OSA is based on two Eli Lilly-sponsored trials published in the New England Journal of Medicine. The trials involved nearly 470 participants, including individuals using continuous positive airway pressure (CPAP) machines—a common but often challenging OSA treatment.

The studies assessed participants using the apnea-hypopnea index (AHI), which measures the frequency of breathing interruptions during sleep.

- In the first trial, where participants did not use CPAP, Zepbound reduced AHI events by an average of 25 per hour after one year, compared to just five events in the placebo group.

- In the second trial, involving CPAP users, Zepbound reduced events by 29 per hour on average, compared to six in the placebo group.

Participants also experienced significant weight loss, averaging 18 per cent to 20 per cent of their body weight (around 45 to 50 pounds) over the course of a year, compared to just 1.6 per cent to 2.3 per cent in the placebo group.

Nearly half of Zepbound users in the trials saw such dramatic improvements that their OSA symptoms were effectively resolved.

While Zepbound offers new hope for people with obesity and OSA, its cost remains a concern. Without insurance, the monthly expense for Zepbound can exceed $1,000. However, Eli Lilly has committed to improving accessibility through patient support programs, including a lower-cost vial option.

The approval could also pave the way for Medicare coverage for OSA treatment, as Medicare currently does not cover medications solely for weight loss.

Zepbound was initially approved for weight management in November 2023, and its expanded use now addresses a critical unmet need for people with obesity-related OSA. This dual benefit makes it a powerful tool for improving overall health.

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