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

Zepbound is part of the GLP-1 receptor agonist class of drugs, which includes popular drugs like Ozempic, which was approved on Dec. 20 to treat moderate to severe OSA in people with obesity. This medication, manufactured by Eli Lilly, is to be used in conjunction with a low-calorie diet and increased physical activity.

“Today’s approval represents the first drug treatment option for some patients with obstructive sleep apnea,” said 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 huge step forward for patients with obstructive sleep apnea.”

What is obstructive sleep apnea?

OSA involves repeated interruptions in breathing during sleep due to blocked airflow. This can lead to serious 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, allowing Zepbound to have a dual effect on weight and Symptoms of sleep apnea Particularly promising.

“Many cases of OSA are not diagnosed and treated, putting millions of people at risk for serious health consequences,” said Patrick 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 included about 470 participants, including individuals using continuous positive airway pressure (CPAP) machines — a common but often challenging OSA treatment.

The study evaluated participants using the apnea-hypopnea index (AHI), which measures the frequency of interruptions in breathing 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 with only five events in the placebo group.

– In the second trial, involving CPAP users, Zepbound reduced events by an average of 29 per hour, compared with six in the placebo group.

Participants experienced significant weight loss, averaging 18 percent to 20 percent of their body weight (about 45 to 50 pounds) over the course of a year, compared to only 1.6 percent to 2.3 percent in the placebo group.

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

While Zepbound offers new hope for people suffering from obesity and OSA, its cost remains a concern. Without insurance, Zepbound’s monthly cost can exceed $1,000. However, Eli Lilly has committed to improving access through patient assistance programs, including low-cost vial options.

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

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

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