The weight loss drug Zepbound, generically known as tirzepatide, has been approved by the Food and Drug Administration (FDA) for the treatment of moderate to severe obstructive sleep apnea (OSA) among adults with obesity. This groundbreaking decision, announced on December 20, marks the first time specific medication has been sanctioned to help manage the condition, which impacts millions of people across the United States.
According to the FDA, sleep apnea occurs when the upper airway becomes blocked, leading to pauses—sometimes lasting for several seconds—in breathing during sleep. Symptoms include loud snoring, fatigue, and, for some, severe health risks such as high blood pressure, stroke, and even depression. Sally Seymour, M.D., director of the Division of Pulmonology, Allergy, and Critical Care at the FDA, expressed her enthusiasm stating, "Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea. This is a major step forward for patients with obstructive sleep apnea."
Zepbound originally gained approval to treat obesity before the recent green light for sleep apnea treatment. Its active ingredient, tirzepatide, works by activating receptors of hormones secreted from the intestine, thereby reducing appetite and food intake, as the FDA reports. Notably, the medication is recommended to be paired with lifestyle changes, such as increased physical activity and reduced calorie intake, for optimal effectiveness.
The approval follows two pivotal clinical trials conducted over 52 weeks. Both trials indicated significant improvements among participants who took Zepbound. Drug users experienced statistically significant reductions in the frequency of shallow breathing episodes compared to those on placebo, showcasing Zepbound's ability to address OSA symptoms potentially linked to patients' weight loss.
Remarkably, nearly half of the patients enrolled in clinical trials observed improvements significant enough to no longer experience symptoms associated with sleep apnea. Patrik Jonsson, senior executive at Eli Lilly, mentioned, "Nearly half of clinical trial patients saw such improvements...marking a significant step forward in reducing the burden of this disease and its interconnected health challenges."
Despite the promising approval, experts from the American Academy of Sleep Medicine (AASM) warn against viewing Zepbound as a universal remedy for all patients suffering from sleep apnea. The organization highlighted through its Dec. 21 statement: "Although excess body weight is the major predisposing factor for sleep apnea, many cases of sleep apnea are related to other factors such as the structure of the jaw and upper airway." This caution signifies the complexity of sleep apnea beyond just body weight.
The introduction of Zepbound has emerged during heightened national interest surrounding weight-loss medications. The drug market has experienced explosive growth, with Eli Lilly recording $3 billion in sales from Zepbound alone during the first three quarters of this year. The FDA, recognizing the surge in demand, previously labeled Zepbound on the shortage list, but as of late December, the agency had resolved the shortage status.
Historically, obstructive sleep apnea has primarily been treated through continuous positive airway pressure (CPAP) machines, which deliver consistent air through masks to keep airways open during sleep. Surgical interventions have also been considered for more severe cases. With the introduction of Zepbound, patients now have pharmaceutical options, supplementing existing therapies.
Coverage for Zepbound is also under scrutiny, particularly concerning Medicare. While there is no specific coverage for weight-loss medications used solely for obesity, there are provisions for conditions exacerbated by obesity, such as Type 2 diabetes and heart disease. Analysts like Juliette Cubanski from KFF see this approval as pivotal for possibly broadening Medicare's coverage on anti-obesity treatments.
This discussion of Medicare coverage is timely, especially against the backdrop of the Biden administration's proposed expansion of coverage for weight-loss drugs for millions on Medicare and Medicaid. The proposed changes could lead to fierce political debates as varying administrations develop different stances on healthcare provisions.
With expanded treatment avenues now available, the FDA's approval of Zepbound for sleep apnea is expected to offer significant relief and hope to those affected by this common but often undiagnosed condition. While many questions about access and affordability persist, the new approval is undoubtedly seen as progress for medical advancements treating conditions traditionally managed with lifestyle changes and mechanical interventions. Patients and advocates are hopeful this approval compels greater attention and resources directed at combating sleep apnea with comprehensive strategies.
