The U.S. Food and Drug Administration (FDA) has approved Zepbound, a weight-loss drug, as the first prescription medication specifically for the treatment of obstructive sleep apnea (OSA) in people with obesity. This approval marks a significant advancement in addressing a condition that affects millions of Americans and is closely linked to obesity.
“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, in the official
announcement. Zepbound, part of the GLP-1 receptor agonists class that includes
the popular drug Ozempic, is recommended alongside a reduced-calorie diet and
increased physical activity. Eli Lilly, the pharmaceutical company behind
Zepbound, highlighted its potential to improve sleep and overall health
outcomes for patients.
Understanding Obstructive
Sleep Apnea
OSA is a prevalent condition affecting up to 30 million
people in the U.S., according to the American Academy of Sleep Medicine. It is
characterized by breathing disruptions during sleep caused by blocked airflow.
Symptoms include snoring, gasping during sleep, and excessive daytime
sleepiness. Left untreated, OSA can lead to severe health complications,
including heart and brain issues.
Weight loss has long been recognized as a key factor in
reducing the severity of OSA. “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 have shown that
nearly half of the participants treated with Zepbound experienced such
significant improvements that they no longer exhibited OSA symptoms.
Clinical Trial Results
The FDA approval of Zepbound is based on two
company-sponsored clinical trials involving approximately 470 participants. The
trials measured improvements using the apnea-hypopnea index (AHI), which tracks
the number of breathing disruptions per hour of sleep. Participants had an
average AHI of about 50 events per hour and a body mass index (BMI) of 39, with
obesity defined as a BMI of 30 or more.
- Non-CPAP
Trial: Patients not using continuous positive air pressure
(CPAP) machines saw an average reduction of 25 AHI events per hour with
Zepbound, compared to a reduction of about five events for those on a
placebo.
- CPAP
Trial: Patients using CPAP machines experienced an average
reduction of 29 AHI events per hour with Zepbound, versus about six events
for those on a placebo.
Participants also experienced substantial weight loss,
averaging 18% to 20% of their body weight—equivalent to 45 to 50 pounds—over a
year. Other benefits included reduced blood pressure and inflammation, which
are critical risk factors for cardiovascular complications associated with OSA.
Accessibility and Cost
The approval of Zepbound for OSA does not expand
eligibility criteria but may lead to broader insurance coverage for Medicare
beneficiaries. Currently, Medicare covers weight-loss medications only when
prescribed for conditions like heart risk reduction. Without insurance,
Zepbound costs approximately $1,060 per month. However, Eli Lilly offers
discounts and a lower-cost vial version for patients to inject manually, making
the treatment more accessible.
Looking Ahead
Zepbound was previously approved in November 2023 for
weight loss in people with obesity or overweight individuals with
weight-related health conditions. This new approval underscores its potential
as a dual-purpose medication for both obesity management and sleep apnea
treatment. Researchers note that the drug’s most common side effects are mild
to moderate gastrointestinal events, typically occurring during dose adjustments.
With this breakthrough, Zepbound offers new hope for
millions of Americans living with OSA, providing a pathway to better sleep,
improved health, and enhanced quality of life.
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