The US Food and Drug Administration (FDA) has approved Eli Lilly's Zepbound (tirzepatide) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity. This marks the first time a medication has been authorized to directly treat patients suffering from this condition.
"Zepbound is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity," Patrik Jonsson, a senior executive at Eli Lilly, stated. The approval is based on results from the SURMOUNT-OSA phase 3 clinical trials, which involved approximately 470 participants.
The trials assessed Zepbound's impact on the apnea-hypopnea index (AHI), a measure of the frequency of breathing interruptions during sleep. Participants who received Zepbound showed a significant reduction in AHI compared to the placebo group. In one study, those taking Zepbound experienced an average of 25 fewer breathing disruptions per hour compared to five with placebo. In the trial involving patients using continuous positive airway pressure (CPAP) machines, those who took Zepbound had about 29 fewer AHI episodes per hour, compared to approximately six for those who took placebo.
Participants treated with Zepbound also experienced substantial weight loss, averaging about 18% of their body weight in the first trial and 20% in the second, compared to 1.6% and 2.3% for those who took placebo. The weight reduction is likely a contributing factor to the improvement in OSA symptoms.
Obstructive sleep apnea is a serious medical condition characterized by blocked upper airways during sleep, leading to breathing interruptions and poor sleep quality. It is closely linked to obesity, and according to the American Academy of Sleep Medicine, OSA affects about 30 million people in the U.S., but the disorder is significantly underdiagnosed.
Until now, treatments for OSA typically involved CPAP machines, which deliver a continuous stream of air through a mask to keep the user's airways open. However, many patients find these options cumbersome or ineffective. The approval of Zepbound offers a new, non-invasive treatment option that could improve the quality of life for those affected.
Zepbound works by activating receptors of hormones secreted from the intestine to reduce appetite and food intake, leading to body weight reduction. Studies have shown that weight loss improves OSA symptoms, and it is likely that the weight loss associated with Zepbound is helping improve this condition in patients.
"Too often, OSA is brushed off as 'just snoring'—but it's far more than that. It's important to understand OSA symptoms and know that treatments are available, including new options like Zepbound," Julie Flygare, J.D., president and CEO of Project Sleep, stated.
Common symptoms of obstructive sleep apnea include loud snoring, gasping for air during sleep, dry mouth, excessive daytime sleepiness, forgetfulness, and morning headaches. OSA not only disrupts sleep quality but also increases the risk of long-term consequences, including cardiovascular problems, diabetes, stroke, and dementia due to temporary cessation of breathing while sleeping.
The most common side effects of Zepbound include gastrointestinal issues like nausea, diarrhea, vomiting, constipation, stomach pain, and indigestion. These side effects are mild to moderate in severity and mainly occur when patients start taking the medication or increase the dose.
Patients are advised not to use Zepbound if they or any of their family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). "Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing or shortness of breath. If you have any of these symptoms, tell your health care provider," the release warned.
The approval may also enhance the drug's insurance coverage in the U.S., potentially leading to broader acceptance by insurers. Currently, some insurance providers, including Medicare, do not offer reimbursement for obesity treatment alone. The new, expanded approval of Zepbound means that insurance providers will likely cover the medication for people with sleep apnea and obesity.
Eli Lilly plans to launch Zepbound for obstructive sleep apnea at the beginning of next year. The company estimates that the new approval applies to about 15-20 million adults in the U.S., offering a significant opportunity to address an unmet medical need.
This development highlights the potential for weight loss medications to treat additional health conditions related to obesity, including sleep disorders. Scientists are studying weight loss drugs for a broad array of conditions, and other pharmaceutical companies are also working to broaden the range of issues their weight-loss drugs can be used to treat.
"Obstructive sleep apnea is still poorly diagnosed. But this is a disease that itself carries cardiovascular risk, as does obesity, so it's great to treat both," Dan Skovronsky, chief scientific officer at Eli Lilly, stated.
The FDA's approval of Zepbound represents a significant milestone in the treatment of obstructive sleep apnea, offering hope to millions of patients who have struggled with limited treatment options. With this new medication, a substantial portion of those affected may find relief from the burdens of this chronic condition.
CNBC, NBC News, Forbes, TIME Magazine, The Washington Post, Medical Dialogues, and The New York Times reported on the approval, among other websites.
The article was written with the assistance of a news analysis system.