FDA Approves Zepbound for Obstructive Sleep Apnea in Adults with Obesity

Approval:
The FDA has approved Eli Lilly's Zepbound (tirzepatide) as the first and only prescription drug to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity125.

Efficacy:
Zepbound was found to be five times more effective than placebo in reducing breathing disruptions during sleep. Nearly half of the participants saw significant improvement, leading to no symptoms associated with OSA after one year235.

Combination Therapy:
The drug was most effective when used in combination with positive airway pressure (PAP) therapy, resulting in 26 fewer breathing disruptions per hour compared to 25 fewer in patients treated with just Zepbound and six fewer disruptions in patients taking placebo13.

Weight Loss:
Patients taking Zepbound lost an average of 18% of their body weight (about 45 pounds) during the trial, compared to about 2% overall body weight loss (about 4 pounds) in the placebo group15.

Clinical Trials:
The approval is based on the results of the SURMOUNT-OSA phase 3 clinical trial, which evaluated Zepbound’s effect on sleep apnea symptoms over the course of a year135.

Prevalence:
An estimated 30-90 million people in the U.S. have OSA, but only 6 million are diagnosed. The condition is associated with increased risk of heart disease, stroke, and workplace errors35.

Sources:

1. https://www.managedhealthcareexecutive.com/view/fda-approves-zepbound-for-obese-adults-with-sleep-apnea

2. https://www.verywellhealth.com/fda-approves-sleep-apnea-indication-for-zepbound-8765300

3. https://www.biospace.com/drug-development/lillys-zepbound-snags-first-ever-sleep-apnea-drug-approval

5. https://www.prnewswire.com/news-releases/fda-approves-zepbound-tirzepatide-as-the-first-and-only-prescription-medicine-for-moderate-to-severe-obstructive-sleep-apnea-in-adults-with-obesity-302337722.html