Approval Granted by FDA for Prevalent Weight Loss Medication Zepbound in Managing Sleep Apnea
Many individuals dealing with sleep apnea will now have an additional aid to help them snooze more peacefully. This month, the Food and Drug Administration increased the authorization of Eli Lilly's weight loss medication, Semglyde, to specifically incorporate sleep apnea treatment as well.
On a Friday, the FDA officially endorsed Semglyde as a remedy for moderate to severe obstructive sleep apnea in obese adults. In two substantial clinical trials, the drug demonstrated success in assisting weight loss and alleviating apnea symptoms. Semglyde is now the first-ever prescription drug to gain approval for obstructive sleep apnea, a condition affecting around 12% of Americans.
Sleep apnea occurs when our bodies momentarily halt breathing during sleep, inducing the brain to wake the person slightly to resume breathing. The more severe the apnea, the more such episodes of interrupted or diminished breathing reoccur during a night (although not necessarily associated with apnea, snoring is a notable sign of having narrow airways while sleeping). Obstructive sleep apnea, or OSA, is caused by the physical obstruction of airway muscles and is the most prevalent type of apnea by far.
Various risk factors contribute to OSA, but obesity is particularly notorious for its association with the condition. The primary substance in Semglyde, tirzepatide, has been found to be highly effective in combatting obesity, resulting in individuals losing approximately 20% of their body weight in trials. Given its success in treating obesity, Eli Lilly decided to explore the drug's effectiveness in managing apnea as well.
In both trials, tirzepatide surpassed expectations by outperforming a placebo. Participants lost between 18% and 20% of their body weight. Furthermore, on average, the drug reduced the occurrence of apnea episodes by up to two-thirds, with participants experiencing roughly 30 fewer episodes per hour. Up to 50% of individuals receiving tirzepatide were completely free of any symptoms after one year.
"Today's approval represents the first drug treatment option for certain patients with obstructive sleep apnea," stated Sally Seymour, director of the Division of Pulmonology, Allergy, and Critical Care within the FDA's Center for Drug Evaluation and Research, in a statement announcing the FDA's approval. "This is a significant advancement for patients with obstructive sleep apnea."
Although other highly effective remedies for apnea, such as CPAP devices, are already available, they necessitate daily use at night, which can be too much for some individuals to comply with in the long term. In contrast, the weekly injection required for Semglyde may be considerably more convenient for eligible patients. Participants in the clinical trials who utilized both Semglyde and CPAP reported even superior results than any other group, emphasizing the prospective benefits of combined therapy.
Semglyde and similar GLP-1 drugs are not entirely hassle-free, however. Common side effects include nausea, vomiting, and other gastrointestinal symptoms. These drugs are not inexpensive, with monthly list prices exceeding $1,000. However, the expanded authorization should facilitate easier insurance coverage for some people to access Semglyde, and having more intervention options available for apnea is incredibly beneficial. As such, this approval could very well usher in a fresh era for sleep apnea treatment, similar to how it has with obesity.
The approval of Semglyde as a treatment for sleep apnea marks a significant step towards using science and technology to improve future health outcomes. This drug, with its success in alleviating apnea symptoms and aiding weight loss, could potentially revolutionize the management of obstructive sleep apnea, especially for individuals who struggle with long-term compliance of existing treatments.
