U.S. Food and Drug Administration (FDA) has approved Zepbound, the first prescription medication for obstructive sleep apnea (OSA). The drug, a GLP-1 receptor agonist, was developed by Eli Lilly and is also recognized for its role in weight loss.
Indications and Usage
Zepbound is approved for individuals with moderate to severe obstructive sleep apnea who are also living with obesity. The treatment is designed to be used in conjunction with a reduced-calorie diet and increased physical activity, according to Eli Lilly’s announcement.
“This is a major step forward for patients with obstructive sleep apnea,” said Dr. Sally Seymour, director of the FDA’s Division of Pulmonology, Allergy, and Critical Care.
Key Findings from Clinical Trials of Zepbound
The FDA’s approval was based on two Eli Lilly-sponsored clinical trials involving approximately 470 participants. These studies demonstrated Zepbound’s effectiveness in reducing the severity of OSA and its associated symptoms:
Trial Results Without CPAP: In participants not using continuous positive airway pressure (CPAP) machines, Zepbound reduced apnea-hypopnea index (AHI) events—measuring breathing disruptions—from an average of 50 to about 25 events per hour after one year. In comparison, the placebo group showed a reduction of about five events per hour.
Trial Results With CPAP: In participants who were using CPAP machines, the drug reduced AHI events by approximately 29 per hour, while the placebo group saw a reduction of about six per hour.
Weight loss with Zepbound
Participants also experienced significant weight loss, with those on Zepbound losing an average of 18–20% of their body weight—equivalent to 45–50 pounds over a year. This contrasts with the placebo group, which reported only a 1.6–2.3% reduction.
The trials also highlighted reductions in blood pressure and inflammation, key factors in reducing cardiovascular risks associated with OSA.
The approval of Zepbound marks its second indication, following its initial FDA clearance for weight loss in November 2023 for individuals with obesity or weight-related health conditions.
Side Effects and Considerations
While the latest approval does not expand the drug’s eligibility, it could enable broader insurance coverage for patients with OSA, particularly those on Medicare. Currently, Medicare covers weight-loss medications only if they are prescribed for conditions beyond obesity.
Without insurance, Zepbound costs approximately $1,060 per month. Eli Lilly offers financial assistance options, including discounts, coupons, and a more affordable version of the drug that requires manual injection.
The most common side effects reported in the trials were mild to moderate gastrointestinal symptoms, particularly during dose adjustments.
Understanding Obstructive Sleep Apnea
Obstructive sleep apnea is a common but often underdiagnosed condition that affects up to 30 million people in the U.S., as per the American Academy of Sleep Medicine. It is marked by interruptions in breathing during sleep due to airway blockages and is closely linked to obesity. This condition not only affects sleep quality but also increases the risk of cardiovascular and neurological complications.
“Many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences,” noted Patrik Jonsson, president of Lilly Cardiometabolic Health. He added that clinical trials revealed “almost half of participants saw such improvements that they no longer had symptoms associated with OSA.”
Read More: Replay 2024 : 7 Food & Health Trends That Defined 2024
