Lilly sees path for Zepbound’s label expansion with Phase III sleep apnea win

Eli Lilly

Lilly sees path for Zepbound’s label expansion with Phase III sleep apnea win

Published: Jun 24, 2024

By Tristan Manalac


Eli Lilly on Friday unveiled detailed findings from the Phase III SURMOUNT-OSA program, showing that its blockbuster weight-loss drug Zepbound (tirzepatide) could significantly improve disease severity in patients with moderate-to-severe obstructive sleep apnea and obesity.

 Tirzepatide treatment reduced the apnea-hypopnea index (AHI) by up to 62.8%, according to data presented at the American Diabetes Association’s 84th Scientific Sessions. For patients, this treatment effect manifested as approximately 30 fewer episodes of restricted or blocked airflow per hour of sleep, compared with placebo.

The tirzepatide treatment also led to high rates of disease resolution, 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 at most 10. The ESS is a standard tool that quantifies a patient’s excessive daytime sleepiness.

In SURMOUNT-OSA 1, 43% of tirzepatide-treated patients reached disease resolution, compared to 14.9% in the placebo group. In SURMOUNT-OSA 2, obstructive sleep apnea (OSA) was resolved in 51.5% of patients in the tirzepatide arm, versus 13.6% in the placebo group.

“There are currently no pharmaceutical treatment options to address the underlying cause of OSA,” Jeff Emmick, senior vice president of product development at Lilly, said in a statement. Approximately, 80 million people in the U.S. suffer from OSA, which disrupts their daily living and “is linked to serious health complications,” according to Emmick.

These data from SURMOUNT-OSA showed that tirzepatide could achieve disease resolution in “a significant portion of patients with moderate-to-severe OSA and obesity,” Emmick said, adding that patients could reach a point where positive airway pressure therapy “may not be recommended.”

The SURMOUNT-OSA program also looked at the safety of tirzepatide in this indication and found that its adverse event profile was consistent with what had been established in prior trials. The most common side effects were gastrointestinal in nature but were generally mild or moderate in severity.

Across both studies, nine patients in the tirzepatide arms dropped out due to toxicities, compared to 10 patients in the placebo group.

Lilly has already filed for a label expansion with the FDA, with a verdict expected as early as the end of 2024, according to the pharma. Friday’s data solidifies Lilly’s case for the OSA indication.

Earlier this month at the Goldman Sachs 45thth Annual Global Healthcare Conference, Lilly Diabetes and Obesity President Patrik Jonsson said that the OSA expansion could help the pharma secure Medicare coverage for Zepbound, giving millions of older adults access to the anti-obesity medication.

In addition to OSA, Lilly is also developing tirzepatide for metabolic dysfunction-associated steatohepatitis. A Phase II readout earlier this month showed that the GLP-1/GIP dual receptor agonist significantly improved liver fibrosis after 52 weeks of treatment.

Source: BioSpace