Lilly Eyes Zepbound Label Expansion After Phase III Sleep Apnea Success

Eli Lilly has announced promising results from its Phase III SURMOUNT-OSA program, demonstrating that its weight-loss drug, Zepbound (tirzepatide), can significantly alleviate the severity of moderate-to-severe obstructive sleep apnea (OSA) in patients who are also obese. The data, presented at the American Diabetes Association’s 84th Scientific Sessions, revealed that tirzepatide could reduce the apnea-hypopnea index (AHI) by as much as 62.8%. This reduction translates to about 30 fewer episodes of restricted or blocked airflow per hour of sleep when compared to a placebo.

The treatment not only decreased the frequency of apnea events but also achieved high rates of disease resolution. Disease resolution was defined as reaching an AHI of fewer than five episodes per hour, or an AHI of five to 14 episodes per hour with an Epworth Sleepiness Scale (ESS) score of 10 or lower. The ESS is a commonly used tool to measure a patient's level of daytime sleepiness.

In the SURMOUNT-OSA 1 study, 43% of patients treated with tirzepatide reached disease resolution, compared to 14.9% in the placebo group. In the SURMOUNT-OSA 2 study, 51.5% of patients in the tirzepatide group reached disease resolution, compared to 13.6% in the placebo group. 

Jeff Emmick, Senior Vice President of Product Development at Lilly, highlighted that there are currently no pharmaceutical treatments available to address the root cause of OSA. He noted that around 80 million people in the United States suffer from OSA, which not only disrupts daily life but is also associated with severe health complications. Emmick emphasized that the SURMOUNT-OSA data indicate that tirzepatide could lead to disease resolution in a significant portion of patients with moderate-to-severe OSA and obesity. He added that this could potentially eliminate the need for positive airway pressure therapy for some patients.

The program also assessed the safety of tirzepatide for this indication, finding that the adverse events profile was consistent with prior trials. The most frequently reported side effects were gastrointestinal but generally mild to moderate in severity. In both studies, nine patients in the tirzepatide groups discontinued treatment due to side effects, compared to ten patients in the placebo groups.

Lilly has already applied for a label expansion with the FDA, with a decision expected by the end of 2024. The recent data strengthens Lilly’s case for extending Zepbound’s use to treat OSA. At the Goldman Sachs 45th Annual Global Healthcare Conference earlier this month, Patrik Jonsson, President of Lilly Diabetes and Obesity, indicated that the OSA indication could help the company secure Medicare coverage for Zepbound, potentially making the medication accessible to millions of older adults.

In addition to treating OSA, Lilly is also exploring tirzepatide for metabolic dysfunction-associated steatohepatitis (MASH). Earlier this month, results from a Phase II study showed that the drug significantly improved liver fibrosis after 52 weeks of treatment, highlighting its potential versatility in treating multiple conditions related to metabolic health.

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