Home » Biotech » Eli Lilly Awaits FDA Decision on Zepbound for Sleep Apnea by Year-End

Eli Lilly Awaits FDA Decision on Zepbound for Sleep Apnea by Year-End

Eli Lilly Awaits FDA Decision on Zepbound for Sleep Apnea by Year-End

Eli Lilly has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for its weight loss drug, Zepbound, to treat obstructive sleep apnea (OSA). The company anticipates a regulatory decision by the end of the year.

If the FDA grants approval, Eli Lilly plans to launch Zepbound for OSA early in 2025, according to Patrik Jonsson, president of Eli Lilly’s diabetes and obesity division.

In conjunction with the application, Eli Lilly released new data from two late-stage clinical trials showing Zepbound’s efficacy in resolving OSA in nearly half of the participants. These findings were presented at the American Diabetes Association’s 84th Scientific Sessions in Orlando, Florida.

“We’re super excited. I think it actually went beyond what most external experts were hoping for,” Jonsson said, commenting on the promising results.

The data supports the potential for additional health benefits from a class of weight loss and diabetes treatments that have gained popularity, causing shortages in the U.S. over the past year. The positive trial results could also help Eli Lilly secure broader insurance coverage for Zepbound, a common hurdle for weight loss medications.

Initial results released in April from the two studies indicated that Zepbound was significantly more effective than a placebo in reducing the severity of OSA in obese patients over a year.

OSA, characterized by interrupted breathing during sleep due to blocked airways, affects an estimated 80 million people in the U.S. According to Jonsson, around 20 million suffer from moderate-to-severe forms of the disorder, but 85% of cases remain undiagnosed.

OSA can lead to loud snoring, excessive daytime sleepiness, and serious complications such as stroke and heart failure. Current treatments often involve wearing cumbersome positive airway pressure (PAP) machines during sleep.

The first study focused on adults with moderate-to-severe OSA and obesity who were not using PAP therapy, while the second included participants who were using and intended to continue PAP therapy. Results showed that 43% of participants in the first study and 51.5% in the second who received the highest dose of Zepbound achieved “disease resolution,” compared to 14.9% and 13.6% in the placebo groups.

“This has huge impacts on patients’ lives,” said Leonard Glass, senior vice president of medical affairs at Eli Lilly, diabetes and obesity. “Imagine not having to use a PAP machine, or not having to worry about waking up again in the middle of the night, or for your partners not having to live with somebody with this condition.”

Researchers assessed the effectiveness of Zepbound using the apnea-hypopnea index (AHI), which measures the frequency of restricted or blocked breathing episodes per hour. Disease resolution for OSA is defined by fewer than five AHI events per hour or a reduction in events coupled with improved scores on a survey measuring daytime sleepiness.

Additional data revealed that 62.3% of patients in the first trial who took Zepbound experienced more than a 50% reduction in AHI events, compared to 19.2% of placebo recipients. In the second study, 74.3% of Zepbound users saw similar reductions, versus 22.9% in the placebo group.

Eli Lilly reiterated that Zepbound met the primary trial objective of reducing AHI events. The drug led to an average reduction of 27.4 AHI events per hour over 52 weeks for participants not using PAP machines, compared to a 4.8% reduction in the placebo group.

For those using PAP machines, Zepbound also showed significant reductions in AHI events compared to the placebo group’s six events per hour.

The FDA has granted Zepbound “fast track designation” for patients with moderate-to-severe OSA and obesity, ensuring expedited review for drugs addressing serious or life-threatening conditions and meeting unmet medical needs.