The FDA has approved Eli Lilly’s Zepbound as the first weight-loss drug to treat obstructive sleep apnea, reshaping care for millions living with obesity-related sleep disorders. The groundbreaking drug improves sleep quality and reduces long-term health risks.
FDA Approval Marks a Milestone for Eli Lilly's Zepbound
Eli Lilly's weight-loss medication Zepbound became the first medicine to be licensed by the US Food and Drug Administration to treat obstructive sleep apnea (OSA), a common sleeping issue, on Friday, Investing.com reports.
According to the business, the medicine has been licensed by the authority for persons with obesity who suffer from moderate to severe obstructive sleep apnea.
At a time when demand for Zepbound is already growing, the approval offers up a huge market of patients for Lilly.
Zepbound's Growing Market Potential and Impact on Insurers
Additionally, it may bolster Lilly's position with commercial insurers and employers who have been hesitant to cover the medicine in the past because of its expensive price.
In the aftermath of the announcement, the Indianapolis-based pharmaceutical company's stock rose 1.14 percent in after-market trade.
Patients with sleep apnea disrupt their sleep cycle and increase their risk of developing long-term consequences including cardiac issues due to the temporary cessation of breathing while sleeping. About one billion individuals around the world are impacted by the illness.
Understanding the Health Risks of Sleep Apnea
"Too often, obstructive sleep apnea is brushed off as 'just snoring' - but it's far more than that," said Julie Flygare, CEO of Project Sleep, a non-profit group.
Surgery, CPAP devices (which require a face mask to be worn while sleeping), and weight loss are common ways to address the disease.
The diabetes medications Zepbound and Mounjaro, manufactured by Lilly, are both referred to as tirzepatide. These treatments are part of a class known as GLP-1 agonists.
They decrease the emptying of the stomach and lessen food cravings; they were initially created for type 2 diabetes.
Clinical Trials Highlight Zepbound's Effectiveness for Sleep Apnea
U.S.-based Lilly and Danish competitor Novo Nordisk are racing to prove that their obesity medications have additional health advantages by evaluating them for a variety of illnesses.
When fresh evidence demonstrates that treatment is successful in different therapeutic areas, regulators have the option to broaden its approval.
Two studies with 469 participants found that Zepbound helped alleviate breathing issues in people with moderate to severe obstructive sleep apnea, which led to the FDA's approval.
Up to 52% of patients in these trials were able to resolve the illness after taking the medicine, according to the full data disclosed in June by the pharmaceutical.
Policy Changes Could Impact Access to Weight-Loss Medications
The so-called biomarkers of sleep apnea, such as low blood oxygen and blood pressure, which can suggest heart disease, were also reduced by Zepbound, according to trial data.
Medicare plans that are sponsored by the government cannot pay for weight loss therapies, even though the Biden administration has suggested increasing coverage for anti-obesity medications.
The proposal would go into force in 2026 if it had the support of the new administration of President-elect Donald Trump.
After obtaining clearance for reducing the risk of heart attacks and strokes in March, Novo Nordisk's Wegovy was the only medication that Medicare began to cover.


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