The FDA has approved Zepbound (tirzepatide) as the first drug for treating moderate-to-severe obstructive sleep apnea (OSA) in obese adults, offering a new treatment option for millions. The approval, announced by Eli Lilly, marks a significant advancement in addressing OSA, a condition affecting an estimated 30 million Americans.
Zepbound is a glucagon-like peptide-1 (GLP-1) receptor agonist already approved for weight loss. The FDA's decision allows its use for OSA specifically in adults with obesity, to be used alongside a reduced-calorie diet and increased physical activity.
Clinical Evidence Supporting Approval
The FDA's approval is based on data from the SURMOUNT-OSA phase 3 clinical trials. These trials involved 469 adults without type 2 diabetes and evaluated Zepbound's efficacy in reducing sleep apnea symptoms. One study included participants using positive airway pressure (PAP) therapy, while the other enrolled participants unable or unwilling to use PAP.
Key findings from the trials include:
- Significant Reduction in Apnea-Hypopnea Index (AHI): Participants receiving Zepbound experienced a statistically significant and clinically meaningful reduction in events of apnea or hypopnea compared with placebo.
- Higher Remission Rates: A greater proportion of participants treated with Zepbound achieved remission or mild OSA with resolution of symptoms compared to placebo.
- Significant Weight Loss: Participants treated with Zepbound had a significant decrease in body weight compared with placebo at 52 weeks. The improvement in AHI in participants with OSA is likely related to body weight reduction with Zepbound.
In the trial where participants weren't using CPAP machines, those using Zepbound had about 25 fewer AHI breathing events per hour, on average, after a year of treatment, compared with a reduction of about five for those on a placebo. In the trial in which participants were on CPAP machines, those on Zepbound had about 29 fewer events per hour, compared with about six for those on placebo.
Expert Perspectives
"Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea," said Sally Seymour, M.D., director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research. "This is a major step forward for patients with obstructive sleep apnea."
Patrik Jonsson, executive vice president, and president of Lilly Cardiometabolic Health and Lilly USA, said, "Zepbound is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity. Nearly half of clinical trial patients saw such improvements that they no longer had symptoms associated with OSA, marking a critical step forward in reducing the burden of this disease and its interconnected health challenges."
Understanding Obstructive Sleep Apnea
OSA is characterized by repeated episodes of upper airway blockage during sleep, leading to pauses in breathing and reduced oxygen levels. Obesity is a major risk factor for OSA due to excess pharyngeal fat in the neck, which obstructs airflow during sleep. Symptoms include:
- Loud snoring
- Daytime sleepiness
- Decreased concentration
- Difficulty sleeping
- Difficult-to-control high blood pressure
Considerations for Treatment
While Zepbound offers a promising new option, it is not without risks. Common side effects include nausea, diarrhea, vomiting, constipation, and abdominal discomfort. The drug also carries warnings for pancreatitis, gallbladder problems, hypoglycemia, acute kidney injury, and diabetic retinopathy. It is contraindicated in patients with a personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2.
Moreover, the American Academy of Sleep Medicine (AASM) supports the FDA’s approval but emphasizes that Zepbound is not a standalone solution for all OSA patients. The AASM recommends continued weight loss and lifestyle changes alongside Zepbound treatment and notes that some patients may require additional interventions.
Implications for Healthcare
The approval of Zepbound could lead to increased insurance coverage for obesity medications, particularly for those with OSA. However, the high cost of the drug remains a barrier for many patients. Eli Lilly offers discounts and coupons to help offset the cost, but out-of-pocket expenses can still be substantial.
Despite these challenges, Zepbound represents a significant advancement in the treatment of OSA, offering a new hope for patients struggling with this common and debilitating condition.
