The U.S. Food and Drug Administration (FDA) has granted its approval for Eli Lilly and Company's Zepbound (tirzepatide) to treat moderate-to-severe obstructive sleep apnea (OSA) among adults who are obese. This milestone marks Zepbound as the first and only prescription medication approved for this condition, aimed at alleviating the significant health burdens associated with disrupted sleep patterns caused by OSA.
Obstructive sleep apnea is characterized by pauses or shallow breathing during sleep, leading to potential long-term health risks, especially among individuals with obesity. According to Patrik Jonsson, president of Lilly USA, "Zepbound is the first medication to significantly improve moderate-to-severe OSA and aids in long-term weight loss among adults with obesity." This statement highlights the drug's dual benefit for those suffering from this prevalent sleep disorder.
The FDA's approval, announced late Friday, signals optimism not only for patients but also for Eli Lilly, whose stocks have fluctuated positively following positive trial outcomes. The approval is particularly timely, as OSA affects up to 30 million people across the United States, often going undiagnosed and untreated.
The clinical trials supporting Zepbound's approval revealed substantial results. Participants who used the drug experienced significant reductions in breathing disruptions—averaging 25 fewer episodes per hour compared to only five with placebo for those not using positive airway pressure (PAP) therapy. Meanwhile, those using PAP therapy saw almost 29 fewer disruptions per hour on Zepbound versus six with placebo. These findings underline the efficacy of Zepbound, which was already recognized for its role as an anti-obesity drug.
Over the course of the studies, Zepbound was proven to contribute to notable weight loss as well. Adults taking Zepbound without PAP therapy lost approximately 45 pounds, representing about 18% of their body weight, whereas those combined with PAP therapy lost around 50 pounds, or 20% of their body weight. These results showed the comprehensive health benefits the medication can provide, with almost half of trial participants reporting total remission of their OSA symptoms after one year on Zepbound. "Nearly half of clinical trial patients saw such improvements they no longer had symptoms associated with OSA," emphasized Jonsson, showcasing the drug's potential for dramatic health improvements.
Eli Lilly's Zepbound is positioned as part of the growing class of GLP-1 receptor agonists, which also includes well-known drugs like Novo Nordisk's Ozempic and Wegovy. These medications have surged in popularity as more patients seek effective treatments for obesity and depression—a trend compounded by shifting health policies targeting obesity management.
Despite Zepbound's high price, which can reach $1,060 monthly without insurance coverage, Lilly has instituted programs aimed at making this life-changing medication more accessible to those within reach, through discounts and coupons. While Zepbound’s approval does not expand the number of eligible individuals for the treatment beyond those already covered by obesity criteria, it could prompt reforms for insurance coverage concerning those needing treatment for sleep apnea, paving the way for patients to receive necessary care.
Looking forward, Lilly has ambitious expectations for both Zepbound and its anti-diabetes counterpart, Mounjaro. With plans to apply for additional indications, including heart failure treatments, there exists the potential for broadening its market appeal and enhancing profits, solidifying its status as pivotal to Lilly's revenue-generative unique formulations.
Experts agree on the necessity of new approaches to tackle undiagnosed obstructive sleep apnea. Addressing this health issue is particularly pertinent during societal shifts toward preventive health measures. Jonsson noted, "Many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences." This reinforces the urgent need for effective therapeutic options like Zepbound.
The FDA approval for Zepbound follows extensive clinical scrutiny, affirming both its safety and effectiveness as evidenced by the SURMOUNT-OSA phase 3 trials involving approximately 470 participants across various countries, including the U.S. and Australia. Data revealed substantial health improvements, including reductions in apnea episodes and overall body weight following administration of the medication.
Overall, Zepbound’s approval is more than just another milestone for Eli Lilly; it ushers in renewed hope for many with obesity-related obstructive sleep apnea, offering both symptom relief and significant weight loss potential—an intertwined solution for debilitating health challenges facing millions.
