FDA Approves Tirzepatide as First Drug for Obstructive Sleep Apnea with Obesity

The US FDA approved tirzepatide (Zepbound; Eli Lilly and Company) on December 20, 2024, as the first and only prescription medication indicated for adults with moderate-to-severe obstructive sleep apnea (OSA) who also have obesity, according to a company news release.¹

"Today, many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences," said Patrik Jonsson, executive vice president, and president of Lilly Cardiometabolic Health and Lilly USA. "Zepbound is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity. Nearly half of clinical trial patients saw such improvements that they no longer had symptoms associated with OSA, marking a critical step forward in reducing the burden of this disease and its interconnected health challenges."

This marks the second indication for tirzepatide in just more than a year, following its November 2023 approval for adults with obesity or overweight and weight-related medical problems.

The December 20, 2024, approval was supported by results from the SURMOUNT-OSA phase 3 clinical trial.¹ SURMOUNT-OSA was a multi-center, randomized, double-blind, placebo-controlled, master protocol designed to evaluate the efficacy and safety of tirzepatide in two patient populations: adults with moderate-to-severe OSA and obesity who were unable or unwilling to use positive airway pressure (PAP) therapy (Study 1), and those who were using and planned to remain on PAP therapy during the trial (Study 2).¹

The primary objective of both studies was to determine whether tirzepatide was superior to placebo in changing the apnea-hypopnea index (AHI) from baseline at 52 weeks.¹ Patients were titrated from a starting dose of 2.5 mg up to a maximum tolerated dose (MTD) of 10 mg or 15 mg, increasing by 2.5 mg every four weeks. Those who tolerated 15 mg remained at that dose, and those who did not tolerate 15 mg continued on 10 mg once weekly.¹

The data showed that tirzepatide was approximately five times more effective than placebo in reducing breathing disruptions among patients not on PAP therapy, lowering their AHI by an average of 25 events per hour compared with 5 events per hour for placebo.¹ In patients on PAP therapy, tirzepatide lowered the AHI by 29 events per hour compared with 6 events per hour for placebo.¹ After one year, up to 50% of adults receiving tirzepatide experienced remission or mild, nonsymptomatic OSA compared with significantly fewer patients in the placebo group.

Patients also experienced substantial weight loss, averaging 45 lb (18% of body weight) for those not on PAP therapy and 50 lb (20%) for those on PAP therapy, versus 4 lb (2%) and 6 lb (2%) for placebo, respectively.¹ Tirzepatide is indicated to be used alongside a reduced-calorie diet and increased physical activity.

Obstructive sleep apnea, characterized by repeated upper airway collapses during sleep, is often underdiagnosed and can lead to significant daytime sleepiness, cardiovascular complications, and other health risks.¹ With this approval, clinicians have a new therapeutic option that targets both OSA severity and obesity, potentially improving outcomes and reducing the burden of this interconnected disease.

"Too often, OSA is brushed off as 'just snoring' — but it's far more than that," said Julie Flygare, J.D., president and CEO of Project Sleep, in the news release¹ . "It's important to understand OSA symptoms and know that treatments are available, including new options like Zepbound. We hope this will spark more meaningful conversations between patients and health care providers and ultimately lead to better health outcomes."

Reference

1. Eli Lilly and Company. FDA approves Zepbound® (tirzepatide), the first and only prescription medication for moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. News release. December 20, 2024. Accessed December 20, 2024. https://zepbound.lilly.com