On December 20, the U.S. Food and Drug Administration (FDA) approved Zepbound (tirzepatide), a weight-loss drug, as the first pharmacologic treatment for obstructive sleep apnea (OSA). Manufactured by Eli Lilly, Zepbound’s approval marks a significant step forward in the treatment of this common sleep disorder, particularly among overweight and obese individuals.
The approval comes after promising results from a clinical trial conducted by Lilly, which showed that Zepbound significantly reduced breathing interruptions in people with OSA. According to the data submitted to the FDA in April, individuals who were overweight or obese and took Zepbound experienced a 63% reduction in a standard measure of restricted breathing. On average, they saw 30 fewer interrupted sleep events per night compared to those who were given a placebo.
The study, which followed participants for a year, consisted of two main analyses. One group received Zepbound alone, while another group combined the drug with a positive airway pressure (PAP) device, a common treatment for sleep apnea. This group was compared to individuals who used a placebo alongside the PAP device. Participants using both Zepbound and PAP showed a reduction in breathing interruptions, although those in the PAP group were likely experiencing more severe sleep apnea, making the comparison less direct.
Dan Skovronsky, Chief Scientific Officer at Eli Lilly, described Zepbound as “the first pharmacologic therapy that can treat obstructive sleep apnea in this way,” emphasizing the drug’s dual benefit in addressing both obesity and sleep apnea. Obstructive sleep apnea occurs when the muscles in the throat relax, blocking air passages, and excess fat tissue can exacerbate this blockage. By aiding in weight loss, Zepbound helps open the airway and reduces the frequency of breathing obstructions during sleep.
The approval is particularly significant for individuals who struggle with both obesity and sleep apnea, conditions that often go hand in hand. Studies conducted by Lilly suggest that Zepbound may also benefit people with heart failure and kidney disease by reducing the progression of these conditions.
Despite its effectiveness, Skovronsky noted that obstructive sleep apnea is often underdiagnosed. With this new FDA indication, doctors can more effectively treat patients suffering from both obesity and sleep apnea, helping to address the cardiovascular risks associated with both conditions.