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December 23, 2024 — The U.S. Food and Drug Administration (FDA) has approved Zepbound (tirzepatide) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity. This groundbreaking approval makes Zepbound the first drug treatment available for certain patients suffering from OSA, marking a significant advancement in the management of this condition.
Obstructive sleep apnea occurs when the upper airway becomes blocked, leading to pauses in breathing during sleep. Although OSA can affect anyone, it is most prevalent in individuals with overweight or obesity. Zepbound, which works by activating receptors of hormones secreted from the intestine (GLP-1 and GIP), reduces appetite and food intake, promoting weight loss. Studies have shown that this reduction in body weight can also improve OSA symptoms.
“This approval represents a major step forward for 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. “Zepbound offers an innovative option for managing moderate to severe OSA in adults with obesity.”
Zepbound’s approval was based on two randomized, double-blind, placebo-controlled studies involving 469 adults without type 2 diabetes. Participants were either using positive airway pressure (PAP), the standard treatment for OSA, or were unable or unwilling to use PAP. Over a 52-week period, participants who received either 10 or 15 milligrams of Zepbound experienced a significant reduction in the apnea-hypopnea index (AHI) — a measure of breathing events during sleep. Those treated with Zepbound also showed greater improvements in OSA symptoms, with many achieving remission or mild OSA compared to those on placebo.
In addition to improving OSA, participants treated with Zepbound also experienced significant weight loss, which is believed to contribute to the reduction in apnea and hypopnea events.
While Zepbound represents a promising treatment option, it does come with potential side effects. These include nausea, diarrhea, vomiting, constipation, abdominal discomfort, and fatigue. In some cases, patients may experience allergic reactions, including fever and rash. Serious side effects may include pancreatitis, gallbladder issues, and kidney complications. Zepbound also carries a warning due to its potential to cause thyroid tumors in rats, though it is unknown whether the drug has similar effects in humans. As such, it should not be used by individuals with a history of medullary thyroid cancer or certain genetic conditions.
The approval of Zepbound follows the drug’s designation as a Fast Track, Priority Review, and Breakthrough Therapy by the FDA, underscoring its potential to address an unmet need in OSA treatment.
The FDA granted the approval to Eli Lilly and Co., the pharmaceutical company behind Zepbound. For patients with moderate to severe OSA, Zepbound offers a new avenue for treatment, particularly when used in conjunction with a reduced-calorie diet and increased physical activity.
For more information about Zepbound, consult a healthcare provider.
