Zepbound Approved as First Drug for Obstructive Sleep Apnea in Obese Patients

On December 23, 2024, the U.S. Food and Drug Administration (FDA) made a significant advancement in the treatment of obstructive sleep apnea (OSA) with the approval of Zepbound, a prescription medication developed specifically for this condition. Announced in a recent statement, the FDA highlighted Zepbound as part of the GLP-1 receptor agonist class of drugs, which includes Ozempic, and noted its intended use for moderate to severe OSA in individuals struggling with obesity.

This groundbreaking approval was confirmed by Dr. Sally Seymour, who leads the Division of Pulmonology, Allergy, and Critical Care at the FDA’s Center for Drug Evaluation and Research. Dr. Seymour emphasized that this development represents a substantial step forward in providing medical treatment options for patients affected by OSA, a condition marked by disrupted breathing during sleep due to blocked airflow, affecting an estimated 30 million Americans.

Eli Lilly, the pharmaceutical company behind Zepbound, has specified that the medication should be used in conjunction with a reduced-calorie diet and increased physical activity. Patrik Jonsson, president of Lilly Cardiometabolic Health, underscored the importance of this approval, pointing out that undiagnosed and untreated cases of OSA leave many at risk for severe health repercussions. Clinical trials have shown promising results, with nearly half of the participants taking Zepbound experiencing significant symptom improvement to the point of resolution.

The FDA’s decision to approve Zepbound for treating sleep apnea is supported by two pivotal trials sponsored by Eli Lilly, which were published in the New England Journal of Medicine. These studies involved about 470 participants, some of whom were utilizing continuous positive airway pressure (CPAP) machines, a common treatment for OSA. The trials evaluated the apnea-hypopnea index (AHI), a key indicator of the frequency of breathing disturbances during sleep.

In one of the trials where participants were not using CPAP machines, Zepbound demonstrated a notable reduction in AHI events, decreasing them by an average of 25 per hour after one year. This contrasts significantly with the placebo group, which saw only a five-event reduction. In the trial that included CPAP users, the reduction was even greater, with Zepbound decreasing events by 29 per hour on average, compared to just six in the placebo cohort.

Additionally, participants on Zepbound experienced substantial weight loss, shedding between 18% and 20% of their body weight—approximately 45 to 50 pounds—over the course of one year. Those on placebo, however, only lost a much smaller percentage of their body weight, ranging from 1.6% to 2.3%. Originally approved for weight management in November 2023, Zepbound now extends new possibilities for individuals battling both obesity and OSA, according to Eli Lilly.

While the FDA’s approval currently targets individuals with obesity, there is the potential for this to facilitate Medicare coverage for those with sleep apnea, addressing a critical gap since Medicare does not cover medications solely for weight loss. To enhance accessibility, Eli Lilly has committed to supporting patients through various programs, including more affordable options. Nevertheless, the out-of-pocket cost for Zepbound, without insurance, can still exceed $1,000 monthly.