Eli Lilly and Company has made waves with the recent approval of its drug Zepbound, which the U.S. Food and Drug Administration (FDA) has sanctioned as the first prescription medication for adults grappling with moderate-to-severe obstructive sleep apnea (OSA) and obesity. This groundbreaking approval, announced on December 23, 2024, marks a significant milestone, especially considering the vast number of individuals affected by this debilitating condition.
The importance of Zepbound cannot be overstated. Obstructive sleep apnea affects approximately 50 to 80 million people across the United States, with nearly 20 million suffering from its moderate-to-severe forms. This sleep disorder is often overlooked, unfairly simplified to mere snoring, when it’s actually far more complex and harmful. "It’s important to understand OSA symptoms and know treatments are available, including new options like Zepbound," acknowledged Julie Flygare, J.D., President and CEO of Project Sleep. She advocates for increased awareness and recognition of OSA, knowing how it affects not just sleep quality but overall health and productivity.
Obstructive sleep apnea arises when the upper airway collapses fully or partially during sleep, leading to breathing interruptions. This can result in dangerous drops in oxygen saturation and frequent awakenings, leaving sufferers fatigued and unrested. Many cases of OSA go undiagnosed or untreated, placing millions at risk for serious health complications. “Today, many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences,” stated Patrik Jonsson, executive vice president and president of Lilly Cardiometabolic Health and Lilly USA.
Zepbound is more than just another weight-loss drug; its efficacy extends to treating OSA symptoms significantly. The FDA reached this decision following encouraging findings from the SURMOUNT-OSA phase 3 clinical trials, where Zepbound demonstrated astounding results. Patients utilizing Zepbound experienced roughly five times more significant reductions in breathing disruptions compared to those on placebo, with reductions averaging 25 fewer apneas or hypopneas per hour without using positive airway pressure (PAP) therapy. Even for patients undergoing PAP treatment, the outcomes were impressive—showing 29 fewer disruptions per hour versus 6 for placebo.
Further cementing its status as a viable treatment choice, the trials revealed astonishing side benefits: patients on Zepbound lost, on average, 45 pounds (approximately 18% of their body weight) over the yearlong study. Those also utilizing PAP therapy registered even greater losses—about 50 pounds, or 20%. To compare, participants on the placebo experienced minimal weight loss, underscoring Zepbound’s transformative potential for those suffering from obesity-related sleep apnea.
The approval of Zepbound paves the way for broader insurance coverage for obesity-related treatments, potentially extending Medicare options for many Americans. Eli Lilly's approval positions it distinctly against competitors, including Novo Nordisk and its weight loss drug Wegovy, which lacks specific approval for sleep apnea treatment. The hype surrounding Zepbound has translated to stock momentum for Eli Lilly, with shares rising as investors recognize the future financial returns from this new indication.
Financially, Eli Lilly saw substantial third-quarter revenue, totaling $11.44 billion, which was reflective of a 20% increase year-over-year. Notably, Zepbound accounted for around $1.26 billion of this total, highlighting the drug's contributions to the company’s growth and focus.
While Zepbound's approval is welcomed news, it also serves as a reminder of the pressing need for awareness about sleep apnea and its accompanying symptoms. Many Americans remain unaware of their condition, and the introduction of Zepbound has the potential to change this narrative by encouraging more discussions between patients and healthcare providers. “Zepbound is the first medication to significantly improve moderate-to-severe OSA and aids long-term weight loss,” Jonsson notes. This new treatment option could spur conversations about symptom recognition and the importance of timely intervention.
With the launch of Zepbound, Eli Lilly may revolutionize care for obstructive sleep apnea, addressing both the disorder itself and the accompanying issue of obesity. This twin approach not only signifies meaningful advancements in the treatment space but may also decrease the overall burden posed by these interrelated health challenges.
Overall, the FDA’s approval marks the dawn of new possibilities for those suffering from obstructive sleep apnea, and with Zepbound now on the market, the hope is to see elevated awareness leading to improved health outcomes.
